System and method for low-profile occlusion balloon catheter

ABSTRACT

An occlusion catheter system includes a proximal hub having an inflation connection port and an inflation pathway. An inflation catheter member is connected to the proximal hub and has an inflation lumen. A stiffener member defines a longitudinal axis. The proximal end of the stiffener member is connected to the proximal hub. The stiffener member extends through a portion of the inflation lumen. An occlusion balloon has a proximal balloon end and a distal balloon end. A distal catheter member is positioned substantially on the longitudinal axis and is connected to the distal end of the stiffener member. An atraumatic tip is positioned on a distal end of the distal catheter member. The atraumatic tip has a substantially circular profile in a relaxed configuration. A pressure sensor is connected to the occlusion catheter system distally relative to the occlusion balloon and is connected to a processor by electrical wiring.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/133,193, filed Sep. 17, 2018 and titled, “System and Methodfor Low-Profile Occlusion Balloon Catheter,” which is a continuation ofU.S. patent application Ser. No. 15/551,504, filed Aug. 16, 2017 andtitled, “System and Method for Low-Profile Occlusion Balloon Catheter,”and issued as U.S. Pat. No. 10,149,962 on Dec. 11, 2018, which is aSection 371 of International Patent Application No. PCT/US2016/023223,filed Mar. 18, 2016, which was published in English on Sep. 22, 2016 asInternational Publication No. WO 2016/149653 and claims the benefit ofU.S. Provisional Patent Application Nos. 62/135,552, filed Mar. 19, 2015and titled, “Anti-Hypertensive Vascular Occlusion Catheter and Method,”62/135,528, filed on Mar. 19, 2015 and titled, “Anti-HypertensiveVascular Occlusion Catheter with Electromechanical Actuation andMethod,” 62/135,576, filed Mar. 19, 2015 and titled, “Anti-HypertensiveVascular Occlusion Catheter and Method,” 62/135,603, filed Mar. 19, 2015and titled, “Anti-Hypotensive Vascular Occlusion Catheter withElectromechanical Actuation Method,” 62/135,609, filed Mar. 19, 2015 andtitled, “Control Processing System for Regulating Vascular Occlusion andMethod,” 62/136,123, filed Mar. 20, 2015 and titled, “System andApparatus for Vascular Pre-Conditioning and Method,” 62/136,152, filedMar. 20, 2015 and titled, “Vascular Pre-Conditioning Occlusion Catheterand Method,” 62/136,180, filed Mar. 20, 2015 and titled, “VascularOcclusion Catheter with Infusion Capability and Method,” 62/136,230,filed Mar. 20, 2015 and titled, “Vascular Occlusion-Perfusion Catheterand Method,” 62/136,326, filed Mar. 20, 2015 and titled, “VascularOcclusion Catheter with Variable Perfusion Flow and Method,” 62/136,370,filed Mar. 20, 2015 and titled, “Vascular Occlusion-Perfusion Catheterwith Plural Occlusion Members and Method,” 62/136,390, filed Mar. 20,2015 and titled, “Vascular Occlusion-Perfusion Catheter withMechanically Actuated Variable Occlusion-Perfusion Properties andMethod,” 62/136,571, filed Mar. 22, 2015 and titled, “Low ProfileSensing Vascular Occlusion Catheter and Method of Vascular Occlusion,”and 62/204,804, filed Aug. 13, 2015 and titled, “System and Method forLow-Profile Occlusion Balloon Catheter,” the entire contents of each ofwhich are incorporated by reference herein in their entireties.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

This invention was made with government support under Contract No.W911QY-15-C-0099 and grant title “Resuscitative Endovascular BalloonOcclusion of the Aorta (REBOA) Research”, awarded by U.S. Army MedicalMateriel Agency. The government has certain rights in the invention.

BACKGROUND OF THE INVENTION

The present invention pertains generally to vascular occlusion cathetersand methods of vascular pre-conditioning while controlling occlusion andperfusion during an occlusion procedure. Pre-conditioning is employed tomitigate ischemia before, during and/or after a vascular occlusionprocedure, as well as used to reduce or ameliorate the onset ofhypertension during or reduce or ameliorate the onset of hypotensionafter a vascular occlusion procedure. Vascular occlusions may beindicated in either the venous system and/or the arterial system.Endoarterial occlusion is a procedure in which a blood vessel is atleast partially occluded in order to restrict blood flow upstream ordownstream the occlusion site for purposes of a vascular procedure orrepair. It is known that transient hypertension is a risk factor inarterial occlusion, particularly aortic occlusion. Transienthypertension occurs when the blood pressure upstream the occlusion siterises to a potentially unsafe level during the time duration of theocclusion. Upon completion of a procedure requiring arterial occlusion,particularly aortic occlusion, care must be taken during the process ofreestablishing blood flow to reduce or ameliorate the onset ofhypotension. Thus, arterial occlusion carries with it two twin risks,hypertension during the occlusion and hypotension as the occlusion iswithdrawn and blood flow restored, that must be managed.

Temporary aortic occlusion as an operative method to increase proximalor central perfusion to the heart and brain in the setting of shock dueto major trauma is generally known. Despite potential advantages overthoracotomy with aortic clamping, resuscitative endovascular balloonocclusion of the aorta (“REBOA”) for trauma has not been widely adopted.

Many attempts have been made at developing technologies to controlnon-compressible abdominal hemorrhage. For example, non-occlusive,abdominal tamponade procedures have been developed to address theproblem of non-compressible hemorrhage, such as providing introducing anexpandable biocompatible foam into the abdominal cavity to applypressure to the abdominal organs and vasculature. Pharmacologicalefforts have also been developed to address the problem ofnon-compressible hemorrhage. Conventional REBOA procedures are typicallyperformed in an operating room and with the aid of fluoroscopy of otherimaging.

Devices that automate inflation and deflation of a balloon are known.Intra-aortic balloon counterpulsation catheters for blood pressureaugmentation coordinated with electrocardiography signals are alsoknown. Over inflation safety devices are also known, such as apressure-relief valve coupled to an inflation lumen that opens whenpressure within the inflation lumen exceeds a threshold pressure, but isstill that relative pressure within the balloon necessary to maintainocclusion of the blood vessel.

It would be desirable to design, develop and implement a system thatintermittently and automatically releases an occlusion by releasingapposition of an occlusive member against the vascular wall and allowingperfusion past the occlusion member in response to a physiologicalparameter, then re-establishing occlusion in response to potentialchanges in the physiological parameter, either during a vascular repairprocedure to control hypertension or post-repair procedure to controlhypotension.

BRIEF SUMMARY OF THE INVENTION

In accordance with a preferred embodiment of the present invention,there is provided an arterial occlusion catheter system including anoccluding member carried at a distal aspect of a catheter, an atraumaticguiding tip forming a distal end of the catheter and a pressureaccumulator communicating with the occluding member. The atraumaticguiding tip alleviates the need for a guide wire, and, therefore forinitial guide wire placement, allowing the preferred arterial occlusioncatheter to be used in field operations and without the necessity offluoroscopy or other imaging modality.

In accordance with another preferred embodiment of the presentinvention, there is provided an arterial occlusion catheter systemincluding an occluding member carried at a distal aspect of a catheter,an atraumatic guiding tip forming a distal end of the catheter, apressure valve communicating with the occluding member that releaseexpansive force applied to the occluding member to allow perfusion pastthe occluding member when hypertension is present, and a means forre-applying the expansive force to re-establish occlusion when thearterial pressure is normalized.

In accordance with still another preferred embodiment of the presentinvention, there is provided an arterial occlusion catheter systemhaving a computer hardware and software control over the physiologicalparameter set points at which automatic computer controlled occlusion orrelease of occlusion occur, including, without limitation, set pointsfor systolic and/or diastolic arterial blood pressure, heart rate, heartrhythm (including, without limitation, the P, Q, R, S, T and U peaks,their size, timing and duration), blood oxygenation, tissue oxygenationor the presence or absence of metabolic blood products.

In accordance with yet still another preferred embodiment of the presentinvention, there is provided an arterial occlusion catheter systemhaving computer hardware and software control monitoring physiologicalparameter set points for systolic and/or diastolic arterial bloodpressure, heart rate, heart rhythm (including, without limitation, theP, Q, R, S, T and U peaks, their size, timing and duration), bloodoxygenation, tissue oxygenation or the presence or absence of metabolicblood products and which provides visual, auditory or tactile feedbackto a medical practitioner as signals for the medical practitioner totake certain recommended actions based upon the monitored physiologicalparameter set points.

In accordance with still yet another preferred embodiment of the presentinvention, there is provided an arterial occlusion system and method inwhich fluids, such as blood, plasma, saline, blood products or bloodsubstitutes, are infused proximal and/or distal the occlusion site.

In accordance with another preferred embodiment of the presentinvention, there is provided an arterial occlusion system and method inwhich the occlusion member has a geometric conformation such that atdifferent degrees of deployment it assumes different transversegeometric profiles that yield different degrees of arterial occlusionand permit perfusion past the occlusion member. The occlusion member mayhave a torroidal shape when fully deployed and a fluted or corrugatedshape with longitudinally oriented flutes or corrugations and valleysbetween adjacent flutes or corrugations when in its partially deployedstate. Alternatively, the occlusion member may have a helical shape wheneither fully or partially deployed, such that fluid flow around theocclusion member is maintained while at least partially occluding theartery. Further, the occlusion member may have a torroidal shape withvanes, the vanes being either longitudinally oriented or helicallyoriented, the vanes being sufficiently pliant so that they deflect andfold against the occlusion member when the occlusion member is in fullapposition with the vascular luminal wall surface, but pliantly recoverto project from the occlusion member and define fluid flow pathwaysbetween adjacent vanes and past the occlusion member.

In accordance with yet another preferred embodiment of the presentinvention, there is provided an arterial occlusion system and methodhaving a catheter with at least one occlusion member at a distal endthereof, a plurality of fluid flow ports communicating with a commonfluid flow lumen within the catheter and an luminal occluding memberthat is movable within the common fluid flow lumen to open or close oneor more of the plurality of fluid flow ports, thereby controlling thevolume and rate of perfusion fluid flow past the at least one occlusionmember.

While in all preferred embodiments of the present invention, theoccluding member is preferably a balloon, the occluding member may alsoconsist of a woven or non-woven shape memory metal membrane, asuperelastic metal membrane, an elastic metal membrane, a woven ornon-woven polymer material or a shape memory polymer and that theoccluding member may or may not be supported by an expansive orreinforcing frame.

As noted above, arterial hypertension is a frequent result of arterialocclusion for any clinically significant period of time, particularly,in aortic occlusion situations. A need has been recognized to provide acatheter system in which clinically significant hypertension isalleviated automatically and without medical practitioner interventionor control, concurrently with the arterial pressure exceeding apre-determined level upstream in the blood flow from the occlusionmember.

The preferred present invention generally relates to endovasculararterial occlusion catheters that are particularly well suited toemergency or trauma use for REBOA procedures to occlude non-compressiblehemorrhage either in the field, on the battlefield or in emergency roomenvironments where guidance imaging is typically not available. Moreparticularly, the preferred present invention pertains to an arterialocclusion catheter that has an atraumatic guiding tip made of agenerally flexible material, elastic material, shape memory material orsuperelastic material. The atraumatic guiding tip may be formed at leastin part of elastomeric polymer that permits guide wire and fluoroscopyfree guidance of the arterial occlusion catheter to the site requiringocclusion. Still more particular, the present invention relates to a lowprofile aortic occlusion catheter having an atraumatic guiding tipformed of polymer, metal or polymer reinforced with an elastic, shapememory or superelastic material and having a lumen for introducing orwithdrawing fluids from a body into which the catheter is placed and/orfor introducing sensors, adjunctive medical devices or other diagnosticor therapeutic modalities, to determine and evaluate a condition withinthe body, such as arterial pressure or flow rate, to diagnose acondition in the body and/or to treat a condition in the body.

Balloon catheters generally comprise an elongated catheter shaft with adeflated balloon on the distal end of the shaft, and are used in anumber of different medical procedures, including, for example,angioplasty, stent placement, occlusion, drug delivery, etc. Thecatheter is introduced through a percutaneous sheath and maneuvered intothe patient's blood vessels until the balloon is properly positionedacross the stenotic area to be dilated. Once properly in position, theballoon is inflated with liquid one or more times to a predeterminedsize and pressure to widen the coronary passageway and increase bloodflow.

It is desirable for balloon catheters to attain very low profiles inorder to facilitate passage of the balloon across severe and remotevascular obstructions. High strength materials are commonly required inthe design of balloon catheter components to prevent shaft buckling whenthe balloon is inflated. Additionally, high strength materials arerequired so that torque applied to the proximal end of the catheterresults in rotation of the distal tip of the catheter. High flexibilitymaterials are also commonly required in the design of balloon cathetercomponents to maintain a low-profile and avoid trauma or perforation ofthe blood vessels while the catheter is maneuvered through the patient'stortuous vasculature.

However, conventional balloon catheters, particularly those designed foraortic occlusion, generally do not properly balance the need forproximal segment stiffness with the need for a low profile, flexibledistal segment and trackability through the tortious vascular pathwaywithout entry into collateral vessels. A low profile balloon catheterwith a high strength and relatively stiff proximal segment and aflexible distal segment with an atraumatic tip having a design thatrestricts tracking and entry into collateral vessels, which is employedby preferred embodiments of the present invention.

In one preferred embodiment, the devices comprise an elongate catheterhaving a proximal and a distal region. The catheter may also have alumen extending between the proximal and distal regions. An expandableocclusion member, e.g., a balloon, a membrane with or without anexpandable frame or an expandable section of the catheter itself, iscarried at the distal region of the catheter. The catheter in certainpreferred embodiments may include plural expandable occlusion members,i.e., second, third, fourth, etc. expandable occlusion members, at thedistal region of the catheter, proximal and/or distal the firstexpandable occlusion member.

In certain preferred embodiments, the catheter will also include meansfor measuring physiological parameters distal and/or proximal one ormore of the expandable occlusion members, including, for example bloodpressure sensors, heart rate sensors, flow sensors, chemical sensors,temperature sensors, oxygenation sensors, ischemia sensors, biologicalsensors, imaging sensors or the like.

In use, the catheter having one expandable device is located in thedescending aorta so that the expandable device is suprarenal orinfrarenal. The expandable device is then expanded to partially orcompletely obstruct the descending aorta. Cerebral blood flow andcerebral blood pressure rises and is maintained at an increased level,as desired. Cephalic blood pressure and/or cerebral blood flow may bemonitored, and the expandable device adjusted as needed. Therapeuticinstruments may be deployed through the lumen (when present) of theocclusion catheter systems.

In another preferred embodiment, the occlusion member, when expanded,has a maximum periphery that conforms to the inner wall of the vessel,thereby providing a sealed contact between it and the vessel wall. Theocclusion catheter system may have a blood flow or other fluid flowconduit allowing blood flow from a location upstream to a locationdownstream. The preferred devices further include a variable flowmechanism in operative association with the blood conduit, therebyallowing blood flow through the conduit to be adjusted and controlled.The preferred devices can optionally include a manometer and/or pressurelimiter to provide feedback to the variable flow mechanism for precisecontrol of the upstream and downstream blood pressure.

In certain preferred embodiments of the invention, the arterialocclusion catheter system includes an additional access lumen thatallows access and passage of other medical devices or adjunctivetherapies. Devices, such as flow wires, imaging catheters or devices,infusion, atherectomy, angioplasty, hypothermia catheters or devices, orelectrophysiologic study (EPS) catheters, can be introduced through theadditional access lumen to access a position in the blood vessel toprovide diagnostic or therapeutic interventions. Hypothermia is oneexample of an adjunctive therapy that may be delivered using theadditional access lumen of the preferred arterial occlusion catheter.Where cerebral cooling is desired the additional access lumen may beused to introduce cooled blood or other cooled fluids, a cooling wire,or other type of heat exchanger, such as a cooling catheter.

In still another preferred embodiment, the occlusion member comprises afirst balloon mounted to a distal end of the catheter, and a secondballoon mounted on the distal end of the catheter and proximal the firstballoon, with a region of the catheter being intermediate the first andthe second balloons. The first balloon has a first balloon inflationchamber and the second balloon has a second balloon inflation chamber,the first balloon inflation chamber and the second balloon inflationchamber may communicate with a common inflation lumen or, alternatively,may communicate with separate inflation lumens, termed herein, firstinflation lumen and second inflation lumen, such that the first andsecond balloons are either concurrently or separately inflatable. Aperfusion lumen may also be provided in the catheter and communicateswith perfusion openings passing through the wall of the catheter topermit fluids, including blood and blood products to be introducedthrough the catheter. The perfusion openings are preferably locateddistal the first balloon (first perfusion openings), proximal the firstballoon and intermediate the first balloon and the second balloon(second perfusion openings), and/or proximal the second balloon (thirdperfusion openings), or in any combination thereof, such that fluid flowmay be established either concurrently or selectively through all of oronly some of the perfusion openings. Selective fluid flow through theperfusion openings may be accomplished in a number of alternativemanners. For example, a plurality of perfusion lumens may be provided inthe catheter. A first perfusion lumen communicating with the perfusionopenings distal the first balloon, a second perfusion lumencommunicating with the perfusion openings proximal the first balloon andintermediate the second balloon and the first balloon, and a thirdperfusion lumen communicating with the perfusion openings proximal theproximal balloon. Alternatively, a single common perfusion lumen maycommunicate with all of the perfusion openings, and a selector member isdisposed within the perfusion lumen and movable within the perfusionlumen to selectively expose only those perfusion lumens in the catheterregions through which perfusion is desired. A non-limiting example of aselector member comprises a tubular hypotube having non-fenestrated wallsurfaces that is longitudinally movable within the perfusion lumen toselect either the first perfusion openings, the second perfusionopenings or the third perfusion openings, or portions thereof. Thehypotube may, itself, have fenestrations or openings passing through itswall surfaces, wherein rotational movement of the fenestrated hypotubewithin the perfusion lumen will align the hypotube fenestrations withone or more of the perfusion openings to permit fluid flow from thelumen of the hypotube and through the aligned fenestrations andperfusion openings and into the vascular structure.

It will be understood that there are many advantages in using thepartial aortic occlusion devices and methods disclosed herein. Forexample, the devices can be used (1) to provide variable partialocclusion of a vessel; (2) to augment and maintain cerebral perfusion inpatients suffering from global or focal ischemia; (3) to condition thebrain or spinal cord to secrete neuroprotective agents prior to a majorsurgery which will necessitate reduced cerebral or spinal perfusion; (4)to prolong the therapeutic window in global or focal ischemia; (5) toaccommodate other medical devices, such as an atherectomy catheter; (6)prophylactically by an interventional radiologist, neuroradiologist, orcardiologist in an angiogram or fluoroscopy suite; (7) for prevention ofcerebral ischemia in patients undergoing procedures, such as coronarycatheterization or surgery, where cardiac output might fall as a resultof arrhythmia, myocardial infarction or failure; (8) to treat shock,thereby eliminating or reducing the use of systemic vasoconstrictors;(9) to prevent hypotensive neurologic damage during carotid stenting,and (10) to rescue vasospasm induced by hemorrhage or interventionalprocedures.

Provided herein are systems, methods and compositions for an occlusionballoon catheter system comprising: a first catheter member having afirst lumen extending longitudinally through the first catheter memberand open at a distal end of the first catheter member; a second cathetermember having a second lumen extending longitudinally through the secondcatheter member and open at a distal end of the second catheter member,the second catheter member is positioned over and in spaced apartrelationship relative to a proximal section of the first catheter memberforming an annular space between the second catheter member and thefirst catheter member, the proximal section of the first catheter memberresides within the second lumen of the second catheter member and thefirst catheter member extends beyond the distal end of the secondcatheter member, a third catheter member that may comprised a proximalshaft of an atraumatic tip having a third lumen extending longitudinallyand partially through the third catheter member; the third cathetermember is positioned over a distal section of the first catheter member,the third catheter member having a distal section that extends distallyfrom a distal end of the first catheter member such that the first lumenand the third lumen are in fluid flow communication, whereby the secondand third catheter are spaced apart from each other along a longitudinalaxis of the first catheter member with the first catheter memberextending therebetween; an atraumatic tip member having a proximalsection co-axially coupled to a distal end of the third catheter member;and a balloon coupled at its proximal end to the second catheter memberand at its distal end to the third catheter member and in fluid flowcommunication with the second catheter member; the balloon beingpositioned such that the space between the second catheter member andthe third catheter member is within the balloon.

REBOA is preferably performed, as follows:

Step 1: Arterial Access and Positioning of Initial Sheath

Access to the arterial circulation for REBOA for trauma is obtainedthrough the femoral artery. After femoral artery access is obtained, aten to fifteen centimeter (10-15 cm) long sheath is positioned in thefemoral and external iliac artery. Access to the femoral artery can beobtained using several techniques, including: percutaneous, openexposure (i.e., cut down), or exchange over a guide wire from anexisting femoral arterial line. Percutaneous access is commonlyaccomplished under ultrasound guidance. Ultrasound or direct surgicalidentification of the femoral artery lateral to the vein is preferred inthe hypotensive patient without a palpable pulse. Once identified, theartery should be entered at a forty-five degree (45°) angle with ahollow eighteen gauge (18-gauge) needle through which a thirty-fivethousandths inch (0.035″) wire or similarly sized wire can be passed.After the wire has been passed into the artery, the needle is removedand a small incision made at the interface of the wire and the skin.Next the sheath is placed over the wire into the artery. Any time asheath is passed over a wire into the arterial system, the sheath'sinternal dilator is preferably firmly in place to allow a smooth reversetaper from the wire to the diameter of the sheath. Once the dilator andsheath have been advanced over the wire through the skin into theartery, the dilator is removed leaving the sheath as a working portthrough which other maneuvers can be accomplished.

Step 2: Selection and Positioning of the Balloon

Selection of a Balloon: A balloon inflated inside the aorta to occludeflow should be compliant and of large diameter. Stiff or noncompliantballoons pose a risk of arterial damage.

Positioning of the Balloon (Zones of the Aorta): Balloon selectionshould be made in view of the aortic zone to be occluded. Aortic zonescan be considered I, II, and III spanning from cranial or proximal tocaudal or distal. Zone I is preferably considered the descendingthoracic aorta between the origin of the left subclavian and celiacarteries. Zone II preferably represents the para-visceral aorta betweenthe celiac and the lowest renal artery and zone III preferablyrepresents the infrarenal abdominal aorta between the lowest renalartery and the aortic bifurcation, depending on patient anatomy. In mostinstances of shock and pending cardiovascular collapse, the aim is toposition the occlusive balloon to occlude zone I. In this case, a largerdiameter balloon and a longer sheath are advanced into the thoracicaorta. REBOA in zone I typically requires a longer sheath, such as asheath having a forty-five to sixty centimeter (45-60 cm) length, to bepositioned in the descending thoracic aorta to support or hold theballoon against aortic pulsation once it is inflated. Inflation of acompliant balloon in aortic zone III may provide specific utility incases of pelvic or junctional femoral hemorrhage. In this instance, arelatively smaller diameter balloon may be sufficient. Because theaortic bifurcation will support or hold the inflated balloon againstpulsation, this maneuver can potentially be accomplished using a largediameter but shorter sheath, such as ten to fifteen centimeters (10-15cm).

Wire Control and Positioning of the Large Sheath and Balloon:Positioning of the balloon in the aorta preferably takes place over athirty-five thousands inch (0.035″) wire, but is not so limited, andthrough an appropriately sized sheath that takes the place of theinitial sheath previously described. Re-sheathing may be accomplished byinserting a two hundred sixty centimeter (260 cm) long, thirty-fivethousands inch (0.035″) stiff wire (e.g., Amplatz Stiff Wire Guide; CookMedical) through the initial sheath in the femoral artery. The stiffwire is preferably advanced under fluoroscopic guidance or visualizationsuch that the floppy tip is in the distal aortic arch. The extent of thewire outside of the sheath at this point should be noted and marked sothat the wire is not advanced or withdrawn significantly, such as bymore than five centimeters (>5 cm). Failure to maintain control of thewire's insertion depth during this and subsequent maneuvers may resultin inadvertent injury to coronary or cerebral vessels if it is advancedtoo far or an inability to advance the balloon to the occlusion zone ifit is withdrawn.

The initial sheath may be removed and backed off of the wire withpressure held proximally over the femoral artery for hemostasis. Thelarger sheath is then advanced over the wire, preferably lead by itsinternal dilator, through the skin opening and into the femoral andiliac artery. In this manner, the wire acts as a rail over which thelarge sheath or balloon catheter can be advanced or withdrawn as theoperator focuses on the fluoroscopic image.

To occlude zone I, the larger, longer sheath is preferably advanced overthe stiff wire under fluoroscopic guidance into the thoracic aorta tothe desired location of occlusion. Fluoroscopically, zone I can beestimated to exist above the twelfth (12^(th)) rib and below the medialhead of the clavicle. Next, the internal dilator is preferably removedfrom the sheath and the back end of the extended wire. The balloon isnext preferably loaded on and advanced over the stationary wire into andthrough the sheath. Under fluoroscopic visualization, after the balloonadvances from the end of the sheath, it is ready to be inflated. Toocclude zone III typically requires a large diameter but shorter sheath,such as ten to twenty-five centimeters (10-25 cm), to allow passage ofthe balloon into the terminal aorta under fluoroscopic visualization.The concept in this scenario is that once the balloon is inflated, anyaortic pulsation will push the balloon to the terminal aorta and itsbifurcation.

Step 3: Inflation of the Balloon and Securing of the Apparatus

Balloon Inflation: Similar to step 2, inflation of the balloon ispreferably accomplished under fluoroscopic guidance. A large-volumesyringe, usually thirty to sixty milliliters (30-60 mL) is filled with ahalf and half solution of sterile saline and iodinated contrast. Thismixture allows visualization of the balloon inflation as well as morerapid inflation and deflation times by reducing viscosity. Preferablywith fluoroscopy, the balloon is inflated until the outer edges of theballoon change from convex to parallel as the balloon takes on thecontour of the aortic wall. One may notice that during systole, theballoon changes shape and creates a “mushroom cap” as it is pulsedinferiorly. In zone I occlusion, the previously positioned long sheathcan then support the balloon and maintain its position within the aorta.When inflation appears adequate to gain aortic wall apposition andaugment central blood pressure, the three-way stopcock on shaft of theballoon should be turned off toward the balloon to maintain inflationand occlusion while other maneuvers are undertaken.

Securing the Inflated Balloon, Sheath, and Wire Apparatus: It is nextpreferred to hold the balloon, sheath, and wire securely so that nonegenerally change position as the central aortic pressure returns pushingthe balloon caudal. Although the balloon, sheath, and wire can besecured with sutures or an occlusive dressing that pin the apparatus tothe patient, these are preferably observed continuously to limitdownward or caudal migration.

Step 4: Deflation of the Balloon

Once a decision to attempt deflation is made, care is preferably takento deflate the balloon slowly as this step can be anticipated to resultin a decrease in afterload and hypotension. After prolonged ballooninflation or in situations where incomplete resuscitation has occurred,deflation of the balloon can potentially result in reperfusion, washoutof metabolic byproducts, and acidosis. As such, intermittent ballooninflation and deflation is preferred until some hemodynamic stability isrestored.

Step 5: Removal of the Balloon and Sheath

After REBOA is no longer required, the deflated balloon and wire arepreferably removed from the large sheath which is preferably flushedwith heparinized saline, such as one hundred milliliters (100 mL) ofsaline or one thousand (1,000) units of heparin. The relatively largediameter sheaths used to deploy currently available compliant balloonsare best removed with open surgical exposure of the femoral artery. Thiscan be accomplished using a longitudinal or transverse groin incisionwith dissection through the soft tissues overlying the femoral sheath.The femoral artery proximal and distal to the sheath entry site shouldbe exposed to allow control. Proximally, this often requires dissectionfor two to three centimeters (2-3 cm) underneath the inguinal ligamentas an assistant uses a narrow handheld retractor (e.g., short Wylierenal vein retractor) to lift the inguinal ligament off of the femoralsheath. During this maneuver, the surgeon preferably considers thecircumflex iliac veins, which course over the top of the distal externaliliac and proximal common femoral artery. Exposure distal to the sheathentry site preferably includes identification and control of both thesuperficial and profunda femoris arteries.

Once proximal and distal exposure and control have been accomplished,the sheath may be removed. The resulting arteriotomy should be closelyexamined and closed. Restoration of flow through the arterial segment ispreferably confirmed using manual palpation for pulses and use ofcontinuous wave Doppler of both the artery and more distal extremity.Closure of the femoral artery exposure is preferably accomplished inlayers using absorbable suture in the soft tissues and skin.

REBOA can be considered in the following five steps, each with specificprocedural considerations: 1. Arterial access, 2. Balloon selection andpositioning, 3. Balloon inflation, 4. Balloon deflation, and 5. Sheathremoval. REBOA procedures may be conducted under fluoroscopy or othersuitable imaging modality.

There is a need for a device that permits medical practitioners toconduct REBOA procedures without the conventional necessity of usingfluoroscopy or other imaging modality together with the suitability ofusing the device and techniques for field applications outside thehospital or in hospital emergency room settings. In trauma situationswhere a patient is undergoing severe central torso hemorrhaging,particularly when not in a hospital setting, such as on a battlefield oron a public street or highway, imaging capability is simply notavailable to emergency responders or field medical practitioners. Insuch situations, it is preferred to temporarily occlude a central torsohemorrhage so that the patient may be stabilized in the field andtransported to a hospital or other facility in which repair of thetraumatic injury may be conducted.

Injuries in modern warfare are often caused by explosion and relatedhigh-velocity penetrating shrapnel leading to non-compressible bleeding.Non-compressible bleeding accounts for approximately eighty-five percent(85%) of preventable deaths on the battlefield, eighty percent (80%) ofwhich include acute hemorrhage within the abdomen/torso. Abdominalhemorrhage involves injury to the spleen, liver, or retroperitonealvasculature, and is typically non-compressible, meaning that it cannotbe treated by external compression or the application of tourniquets ortopical dressings.

Emergency surgical intervention is currently the only available methodfor treating non-compressible abdominal hemorrhage. Battlefield or othermajor trauma generally occurs in an austere, resource constrainedenvironment, often with extended evacuation time due to persistingtactical threats or environmental constraints. Transport time to reach ahospital where surgery can take place varies, but is estimated toaverage one hour (1 hr). The majority of preventable deaths due toabdominal hemorrhage is nearly fifty percent (50%) and can be attributedto delays in hemorrhage control during transportation, highlighting theneed for rapid, far-forward hemorrhage treatments.

Systems, methods and compositions for an occlusion balloon cathetersystem comprising: a first catheter member having a first and secondlumens extending along a longitudinal axis thereof that forms a proximalsection of the catheter system, a second catheter member having a thirdlumen forming a distal section of the catheter system and coupled to adistal end of the first catheter member, an inflatable balloon coupledat its proximal end to a distal end of the first catheter member and atits distal end to a proximal end of the second catheter member, a firstlumen of the first catheter member terminating within the inflatableballoon to communicate an inflation fluid to an area within theinflatable balloon and a second lumen of the first catheter member beingin fluid flow communication with the third lumen of the second cathetermember; an atraumatic guiding tip coupled to a distal end of the thirdlumen of the second catheter member; and a third catheter member havingat least one lumen passing longitudinally therethrough, the thirdcatheter member being disposed within each of the second lumen of thefirst catheter member and the third lumen of the second catheter memberand passing therethrough.

Preferred embodiments of the present invention have been activelyconceptualized, modeled, iterated and working prototypes produced ofmultiple REBOA related devices. The concepts are responses to thefollowing lists of clinical needs, including (1) Pushing back theischemic injury envelope, (2) Reperfusion mitigation/prevention, (3)Ischemia mitigation/prevention, (4) Hypertension mitigation/prevention,(5) Traumatic brain injury (“TBI”) mitigation/prevention, (6)Pre-hospital use, (7) Rapid deployment, (8) Field specific packaging,(9) Easier to use, and (10) Lower profile

Preferred embodiments of the present invention may also include:

Infusion Catheter

The infusion catheter or occlusion catheter system is a preferablymulti-purpose, low profile, such as approximately five French (5 Fr)catheter, although the preferred system is not limited to cathetershaving this size. The preferred systems may be used independently or inconjunction with a REBOA catheter from the contralateral leg toadminister fluids (i.e. reperfusion mitigation/ischemia prevention) orgas/fluid angiography below the REBOA occlusion balloon. The combinationof the P-tip and hybrid shaft design preferably allow for properplacement in large vessels without needing to be inserted over aguidewire. The infusion catheter of the preferred embodiments may becompatible with power injection.

Smart REBOA

Smart REBOA is a REBOA accessory that can preferably be connected to andused with any REBOA catheter. Smart REBOA preferably controls theocclusion balloon inflation volume and inflation/deflation rate, usingthe patient's own vital signs as feedback. A validated algorithm iscapable of using feedback from a variety of vital signs (i.e. heartrate, respiration rate, pulse oxygenation, blood pressure, etc.) tomodulate the inflation volume of the balloon for an optimized REBOAprocedure.

Decision Support REBOA (DS REBOA)

DS REBOA builds upon the preferred Smart REBOA concept. DS REBOApreferably combines the real time monitoring and feedback of the SmartREBOA device with a historical and constantly updated database of knownREBOA cases and outcomes to provide forward looking possible diagnosesand other decision support information (collectively called‘prognostics’) through sophisticated statistical means. The DS REBOAalso preferably provides a patient specific, real time step throughclinical practice guide and other decision support mechanisms to assistthe clinician.

Power Injection Capable REBOA (PIC REBOA)

PIC REBOA is preferably a REBOA Catheter that is approximately sevenFrench (7 Fr) compatible and offers the same or similar features as theER-REBOA Catheter (balloon occlusion, built-in arterial line, guidewireand fluoroscopy-free), but preferably adds the ability to perform powerinjections. The PIC REBOA is not limited to being seven French (7 Fr)compatible.

REBOA with Above & Below Balloon Lumens (ABBL REBOA)

ABBL REBOA is a REBOA Catheter that preferably offers the same orsimilar features as the ER-REBOA Catheter, but contains an additionallumen below the balloon for fluid/gas injections/sampling. ABBL REBOA ispreferably compatible with power injectors for either above or below theballoon angiography.

REBOA with a Partial Occlusion Balloon (POB REBOA)

POB REBOA is a REBOA Catheter that preferably provides the clinician theability to selectively control the degree of occlusion. Balloon designpreferably permits minimal occlusion, such as ten percent (10%), up tototal or near total occlusion, such as one hundred percent (100%).

REBOA with Large Bore Lumen for High Flow Rate Infusions (LBL REBOA)

LBL REBOA is a REBOA Catheter that preferably includes the same orsimilar features as the ER-REBOA Catheter (balloon occlusion, built-inarterial line, guidewire and fluoroscopy-free), but has a largerdiameter central lumen that provides the ability to perform high flowrate infusions (i.e. selective aortic arch perfusion (SAAP)).

ECMO/Cryogenic/CRRT Adjuncts

Extra Corporeal Membrane Oxygenation (“ECMO”) continues to become moreclinically widespread. ECMO is preferably used in cases where thepatient's lungs have been damaged or temporarily compromised, bybypassing the patient's lungs through the use of catheters to shunt theblood away from the damaged organs and through an ECMO device instead.Recent advances have reduced the size, weight and cost of ECMO, whileimproving its efficacy. Combining the REBOA technology with various ECMOcatheters to provide a “one stop” solution for patients with lung orother major organ compromise in the setting of hemorrhage may become aclinically preferred method. Similar combinations with existing andproposed cryogenic devices and Continuous Renal Replacement Therapy(CRRT) systems also are contemplated.

REBOA with Anti-Hypertension Feature (A-HYPER REBOA)

A-HYPER REBOA is a REBOA accessory that uses the patient's ownsupra-occlusion blood pressure to control the inflation/deflation of theREBOA balloon is contemplated. Should the patient's supra occlusionblood pressure rise dangerously high, potentially increasing the risk ofhemorrhagic stroke, the system preferably automatically and temporarilydeflates the REBOA balloon until the blood pressure drops to a saferlevel.

REBOA with Anti-Hypotension Feature (A-HYPO REBOA)

A-HYPO REBOA is a REBOA accessory that uses the patient's own bloodpressure to control balloon deflation during the removal of the REBOAballoon is contemplated. If the patient's blood pressure should dropdangerously low during the deflation of the REBOA balloon, the systemmay automatically re-inflate the balloon to restore adequate pressure tothe vital organs. The system will then preferably begin a pre-programmedcycle of deflation/repeat inflations until the patient can be weanedcompletely off occlusion.

Inflation Safety Device (ISD)

The ISD is a REBOA accessory that can preferably be used with theER-REBOA Catheter to decrease the risk of over-inflating the balloonduring fluoroscopy-free balloon inflation (i.e. field use). The ISD ispreferably connected in line between the ER-REBOA Catheter and theinflation syringe. The user advances the syringe plunger, pausingoccasionally to read the pressure gauge. When the pressure gauge needlecomes to rest in the ‘blue zone’ or a preferred marked zone of thepressure gauge, proper occlusion has generally been achieved.

Infection Control Sleeve (ICS)

The infection control sleeve (“ICS”) is a REBOA accessory that ispreferably pre-loaded on the ER-REBOA Catheter to minimize the risk ofinfection when the device is deployed in austere environments. TheER-REBOA Catheter with the ICS preferably remains compatible with sevenFrench 7 Fr components and has the same or similar features (balloonocclusion, built-in arterial line, guidewire and fluoroscopy-free) toother preferred REBOA systems and catheters.

Ruggedized, Low Volume (Cube) Packaging (REBOA w/LV PKG)

REBOA w/LV PKG is a modified ER-REBOA Catheter and redesigned,ruggedized, low volume package (approximately twenty-five percent (25%)of the current ER-REBOA package volume) specific configured for fielduse. The ER-REBOA Catheter preferably remains compatible with sevenFrench (7 Fr) components and has the same or similar features (balloonocclusion, built-in arterial line, guidewire and fluoroscopy-free) toother preferred REBOA systems.

Zone 3 REBOA (Z3 REBOA)

The Z3 REBOA is a REBOA Catheter preferably designed for Zone 3placement relative to the aorta. The Z3 REBOA is preferably six French(6 Fr) compatible that has a shorter shaft length and an optimizedballoon for generally less cumbersome Zone 3 placements.

Ultra-Low Profile REBOA (ULP REBOA)

The ULP REBOA is a preferred REBOA system that is compatible with sixFrench or less (≤6 Fr) components. The ULP REBOA is preferably designedand configured for faster placement and improved ease-of-use. Theballoon is filled with carbon dioxide (CO₂), preferably using a pressureregulated system that preferably inflates the balloon to a set pressure,regardless of the diameter of the aorta. The use of the carbon dioxide(CO₂) also enables the catheter shaft to be ultra-low profile, such asless than or equal to six French (≤6 Fr) compatible. An electronic,catheter-based pressure sensor typically requires no priming/flushing,so arterial line measurements can preferably be taken as soon as thedevice is inserted.

REBOA Gas Balloon Inflator (GBI)

The GBI is a REBOA accessory that is preferably used with the ER-REBOACatheter to provide rapid balloon inflation/deflation. The GBIpreferably fills the balloon with carbon dioxide (CO₂) gas to a setpressure, regardless of the vessel diameter, preferably makingpre-hospital balloon inflation less technique dependent.

Guidewire Compatible REBOA (GWC REBOA)

The GWC REBOA is a preferred REBOA Catheter that can be used with aguidewire but doesn't require one and is preferably compatible withseven French (7 Fr) components. The preferred GWC REBOA allows the userto leave behind a guidewire when finished with REBOA for additionalprocedures. The GWC REBOA Catheter preferably, but not necessarily,remains seven French (7 Fr) compatible and has the same or similarfeatures (balloon occlusion, built-in arterial line, guidewire andfluoroscopy-free) to other preferred REBOA systems.

When a fluid is used as the pressure source to activate the occlusionmember, such as to fill an occlusion balloon, that fluid may be aliquid, including water, saline, contrast medium or any combinationthereof, or may be a gas, including carbon dioxide, helium, air oroxygen.

It would be desirable to develop a system that intermittently andautomatically releases an occlusion by releasing apposition of anocclusive member against the vascular wall and allowing perfusion pastthe occlusion member in response to a physiological parameter, thenreestablishing occlusion in response to the same physiologicalparameter.

The methods, systems, and apparatus are set forth in part in thedescription which follows or can be learned by practice of the methods,apparatus, and systems. The advantages of the methods, apparatus, andsystems will be realized and attained by means of the elements andcombinations particularly pointed out in the appended claims and thebelow description. It is to be understood that both the foregoinggeneral description and the following detailed description are exemplaryand explanatory only and are not restrictive of the methods, apparatus,and systems, as claimed or described.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofthe invention, will be better understood when read in conjunction withthe appended drawings. For the purpose of illustrating the invention,there are shown in the drawings embodiments which are presentlypreferred. It should be understood, however, that the invention is notlimited to the precise arrangements and instrumentalities shown. In thedrawings:

FIG. 1 is a top perspective view of a first preferred embodiment of anocclusion catheter system in accordance with the present invention;

FIG. 2 is an enlarged perspective view of the occlusion catheter systemof FIG. 1 taken from within circle 2 of FIG. 1 with a transparentocclusion balloon;

FIG. 3 is a cross-sectional view the occlusion catheter system of FIG. 1, taken along line 2-2 of FIG. 2 .

FIG. 4 is an enlarged perspective view of the occlusion catheter systemof FIG. 1 , taken from within circle 4 of FIG. 1 with a transparentocclusion balloon;

FIG. 5 is a cross-sectional view the occlusion catheter system of FIG. 1, taken along line 5-5 of FIG. 2 directly into the page of FIG. 2 ;

FIG. 6 is a cross-sectional view of the occlusion catheter system ofFIG. 1 , taken along line 6-6 of FIG. 1 ;

FIG. 7 is a combination partial cross-sectional view of the occlusioncatheter system taken along line 7-7 of FIG. 1 and a magnified topperspective view of the occlusion catheter system near a proximal end ofthe occlusion balloon of the occlusion catheter system of FIG. 1 ;

FIG. 8 is a cross-sectional view of the occlusion catheter system ofFIG. 1 , taken along line 8-8 of FIG. 1 ;

FIG. 9 is a magnified top perspective view of a portion of a secondpreferred embodiment of the occlusion catheter system proximate aocclusion balloon of the second preferred occlusion catheter system ofthe present invention;

FIG. 9A is a cross-sectional view of the occlusion catheter system ofFIG. 9 , taken along line 9A-9A of FIG. 9 .

FIG. 9B a combination partial cross-sectional view of the occlusioncatheter system taken along line 9B-9B of FIG. 9 and a magnified topperspective view of the occlusion catheter system near a proximal end ofthe occlusion balloon of the occlusion catheter system of FIG. 9 ;

FIG. 9C is a cross-sectional view of the occlusion catheter system ofFIG. 9 , taken along line 9C-9C of FIG. 9 ;

FIG. 9D is a cross-sectional view of the occlusion catheter system ofFIG. 9 , taken along line 9D-9D of FIG. 9 , wherein the lumens andcatheters are sized differently than the embodiment of FIG. 9C;

FIG. 10 is a magnified top perspective view of an alternative embodimentof a distal portion of the occlusion catheter system of FIG. 9 ;

FIG. 11 is a magnified top perspective view an atraumatic tip of theocclusion catheter system of FIG. 10 , taken from within shape 11 ofFIG. 10 ;

FIG. 12 is a top perspective view of a third preferred embodiment of anocclusion catheter system of the preferred present invention;

FIG. 13 is an enlarged top perspective view of the occlusion cathetersystem of FIG. 12 , taken from within shape 13 of FIG. 12 ;

FIG. 14 is a cross-sectional view of the occlusion catheter system ofFIG. 13 , taken along line 14-14 of FIG. 13 ;

FIG. 15 is a top perspective view of the occlusion catheter system ofFIG. 12 , taken from within shape 15 of FIG. 1 ;

FIG. 16 is a cross-sectional view of the occlusion catheter of FIG. 12 ,taken along line 16-16 of FIG. 12 ;

FIG. 17 is a cross-sectional view of the occlusion catheter system ofFIG. 12 , taken along line 17-17 of FIG. 12 ;

FIG. 18 is a cross-sectional view of the occlusion catheter system ofFIG. 12 , taken along line 18-18 of FIG. 12 ;

FIG. 19 is a diagrammatic rendering of a first preferred pressureregulation system for automatically releasing occlusion by any of theocclusion catheter systems of the first, second and third preferredembodiments of FIGS. 1-18 ;

FIG. 20 is a diagrammatic rendering of a second preferred pressureregulation system for controlling the occlusion balloon of any of theocclusion catheter system of the first, second and third preferredembodiments of FIGS. 1-18 ;

FIG. 21 is a diagrammatic rendering of a third preferred pressureregulation system for controlling the occlusion balloon of any of theocclusion catheter system of the first, second and third preferredembodiments of FIGS. 1-18 ;

FIG. 22 is a diagrammatic rendering of a fourth preferred pressureregulation for controlling the occlusion balloon of any of the occlusioncatheter system of the first, second and third preferred embodiments ofFIGS. 1-18 ;

FIG. 23 is a top perspective view of a first preferred embodiment of analternative occlusion perfusion balloon system that may be utilized withany of the occlusion catheter systems of the first, second and thirdpreferred embodiments of the occlusion catheter system of FIGS. 1-18 ,wherein the occlusion perfusion balloon is in a minimal inflationconfiguration;

FIG. 24 is a rear elevational view of the occlusion perfusion balloonsystem of FIG. 23 ;

FIG. 25 is a top plan view of the occlusion perfusion balloon system ofFIG. 23 ;

FIG. 26 is a top perspective view of the occlusion perfusion balloonsystem of FIG. 23 , wherein the occlusion perfusion balloon is in a lowinflation volume configuration;

FIG. 27 is a top perspective view occlusion perfusion balloon system ofFIG. 23 , wherein the occlusion perfusion balloon is in a mediuminflation configuration;

FIG. 28 is a top perspective view of the occlusion perfusion balloonsystem of FIG. 23 , wherein the occlusion perfusion balloon is in a fullinflation configuration;

FIG. 28A is a cross-sectional view of the occlusion perfusion balloonsystem of FIG. 23 , taken along line 28A-28A of FIG. 28 ;

FIG. 29A is side perspective view of a second preferred embodiment of analternative occlusion perfusion balloon system that may be utilized withany of the occlusion catheter systems of the preferred embodimentsdescribed herein, wherein the occlusion perfusion balloon is in aninflated configuration;

FIG. 29B is a cross-sectional view taken along line 29B-29B of FIG. 29A;

FIG. 30A is a side perspective view of a third preferred embodiment ofan alternative occlusion perfusion balloon system that may be utilizedwith any of the occlusion catheter systems of the preferred embodimentsof the occlusion catheter system described herein, wherein the occlusionperfusion balloon is in an inflated configuration;

FIG. 30B is a cross-sectional view taken along line 30B-30B of FIG. 30A;

FIG. 31 is a side elevational view of fourth and fifth preferredembodiments of an alternative occlusion perfusion balloon system thatmay be utilized with any of the occlusion catheter systems of thepreferred embodiments of the occlusion catheter systems describedherein, wherein the occlusion perfusion balloon is in an inflatedconfiguration;

FIG. 31A is a cross-sectional view of the occlusion perfusion balloonsystem of FIG. 31 , taken along line 31A-31A of FIG. 31 in accordancewith the fourth preferred embodiment;

FIG. 31B is a cross-sectional view of the occlusion perfusion balloonsystem of FIG. 31 , taken along line 31A-31A of FIG. 31 , wherein arestraining filament is incorporated into the occlusion perfusionballoon in accordance with the fifth preferred embodiment;

FIG. 32 is a top perspective view of a sixth preferred embodiment of anocclusion perfusion balloon system comprised of an occlusion perfusionballoon assembly that may be utilized with any of the preferredocclusion catheter systems described herein, wherein the occlusionperfusion balloon assembly is in an inflated configuration;

FIG. 32A is a cross-sectional view of the occlusion perfusion balloonsystem of FIG. 32 , taken along line 32A-32A of FIG. 32 ;

FIG. 33 is a top perspective view of a seventh preferred embodiment ofan occlusion perfusion balloon system that may be utilized with any ofthe preferred occlusion catheter systems described herein, wherein theocclusion perfusion balloon is in an inflated configuration;

FIG. 34 is a top perspective view of a eighth preferred embodiment of anocclusion perfusion balloon system that may be utilized with any of thepreferred occlusion catheter systems of described herein, wherein theocclusion perfusion balloon is in an inflated configuration;

FIG. 35A is a side perspective view of a ninth preferred embodiment ofan occlusion/perfusion balloon system that may be utilized with any ofthe occlusion catheter systems described herein, wherein theocclusion/perfusion balloon is in a partially inflated configurationwithin a vessel;

FIG. 35B is a side elevational view of the occlusion/perfusion balloonsystem of FIG. 35A, wherein the balloon is in the partially inflatedconfiguration;

FIG. 35C is a side elevational view of the occlusion/perfusion balloonsystem of FIG. 35A, wherein the balloon is in a fully inflatedconfiguration;

FIG. 35D is a side perspective view of an occlusion/perfusion balloonsystem in accordance with a tenth preferred embodiment that may beutilized with any of the occlusion catheter systems described herein;

FIG. 36 is a top perspective view of an occlusion catheter system inaccordance with a fourth preferred embodiment of the present invention;

FIG. 36A is a cross-sectional view of the occlusion catheter system ofFIG. 36 , taken along line 36A-36A of FIG. 36 ;

FIG. 36B is a cross-sectional view of the occlusion catheter system ofFIG. 36 , taken along line 36B-36B of FIG. 36 ;

FIG. 36C is a cross-sectional view of the occlusion catheter system ofFIG. 36 , taken along line 36C-36C of FIG. 36 ;

FIG. 37 is a top perspective view of an occlusion catheter system inaccordance with a fifth preferred embodiment of the present invention;

FIG. 37A is a cross-sectional view of the occlusion catheter system ofFIG. 37 , taken along line 37A-37A of FIG. 37 ;

FIG. 37B is a cross-sectional view of the occlusion catheter system ofFIG. 37 , taken along line 37B-37B of FIG. 37 ;

FIG. 37C is a cross-sectional view of the occlusion catheter system ofFIG. 37 , taken along line 37C-37C of FIG. 37 ;

FIG. 38 is a top perspective view of a catheter system in accordancewith a sixth preferred embodiment of the present invention, wherein thesystem is particularly adaptable for use as a hemorrhage exclusionsystem;

FIG. 39 is a top perspective view of a catheter system in accordancewith a seventh preferred embodiment of the present invention, whereinthe system is also particularly adaptable for use as a hemorrhageexclusion system;

FIG. 39A is a cross-sectional view of the catheter system of FIG. 39 ,taken along line 39A-39A of FIG. 39 ;

FIG. 39B is a magnified top perspective view of the catheter system ofFIG. 38 , taken from within shape 39B of FIG. 39 ;

FIG. 40 is a top perspective view of a first preferred inflation controlsystem that may be utilized with any of the occlusion catheter systemsof the first, second and third preferred embodiments of the occlusioncatheter system of FIGS. 1-18 ;

FIG. 41 is a top perspective view of a second preferred inflationcontrol system that may be utilized with any of the occlusion cathetersystems of the first, second and third preferred embodiments of theocclusion catheter system of FIGS. 1-18 ;

FIG. 41A is a cross-sectional view of a third preferred inflationcontrol system that may be utilized with any of the occlusion cathetersystems of the first, second and third preferred embodiments of theocclusion catheter system of FIGS. 1-18 ;

FIG. 42A is a side perspective view of a first preferredinfection/contamination control system that may be utilized with any ofthe occlusion catheter systems of the first, second and third preferredembodiments of the occlusion catheter system of FIGS. 1-18 ;

FIG. 42B is a magnified top perspective view of theinfection/contamination control system of FIG. 42A, taken from withinshape 42B of FIG. 42A;

FIG. 43 is side perspective view of a catheter system in accordance witha eighth preferred embodiment of the present invention, wherein thesystem is adaptable for use with a guidewire;

FIG. 43A is cross-sectional view of the catheter system of FIG. 43 ,taken along line 43A-43A of FIG. 43 ;

FIG. 43B is a side perspective view of an alternative preferred cathetersystem in accordance with the eighty preferred embodiment of the presentinvention;

FIG. 43C is a cross-sectional view of the alternative preferred cathetersystem of FIG. 43B, taken along line 43C-43C of FIG. 43B;

FIG. 44 is bottom perspective view of an occlusion catheter system inaccordance with a ninth preferred embodiment of the present invention,wherein the system is adaptable for use as a power injection compatiblevascular occlusion balloon catheter; and

FIG. 45 is side elevational view of an occlusion catheter system inaccordance with a tenth preferred embodiment of the present invention,wherein the system is also adaptable for use as an infusion catheter.

DETAILED DESCRIPTION OF THE INVENTION

The foregoing and other features and advantages of the invention willbecome more apparent from the following detailed description ofexemplary embodiments, read in conjunction with the accompanyingdrawings. The detailed description and drawings are merely illustrativeof the invention rather than limiting, the scope of the invention beingdefined by the appended claims and equivalents thereof.

Certain terminology is used in the following description for convenienceonly and is not limiting. Unless specifically set forth herein, theterms “a”, “an” and “the” are not limited to one element but insteadshould be read as meaning “at least one”. The words “right”, “left”,“lower” and “upper” designate directions in the drawings to whichreference is made. The words “inwardly” or “distally” and “outwardly” or“proximally” refer to directions toward and away from, respectively, thepatient's body, or the geometric center of the preferred occlusionballoon catheter and related parts thereof. The words, “anterior”,“posterior”, “superior,” “inferior”, “lateral” and related words and/orphrases designate preferred positions, directions and/or orientations inthe human body to which reference is made and are not meant to belimiting. The terminology includes the above-listed words, derivativesthereof and words of similar import.

It should also be understood that the terms “about,” “approximately,”“generally,” “substantially” and like terms, used herein when referringto a dimension or characteristic of a component of the invention,indicate that the described dimension/characteristic is not a strictboundary or parameter and does not exclude minor variations therefromthat are functionally the same or similar, as would be understood by onehaving ordinary skill in the art. At a minimum, such references thatinclude a numerical parameter would include variations that, usingmathematical and industrial principles accepted in the art (e.g.,rounding, measurement or other systematic errors, manufacturingtolerances, etc.), would not vary the least significant digit.

While the invention has been described in connection with variousembodiments, it will be understood that the invention is capable offurther modifications. This application is intended to cover anyvariations, uses or adaptations of the invention following, in general,the principles of the invention, and including such departures from thepresent disclosure as, within the known and customary practice withinthe art to which the invention pertains.

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “lower,” “bottom,” “upper” and “top”designate directions in the drawings to which reference is made. Thewords “inwardly,” “outwardly,” “upwardly” and “downwardly” refer todirections toward and away from, respectively, the geometric center ofthe vascular occlusion catheter system, and designated parts thereof, inaccordance with the present disclosure. Unless specifically set forthherein, the terms “a,” “an” and “the” are not limited to one element,but instead should be read as meaning “at least one.” The terminologyincludes the words noted above, derivatives thereof and words of similarimport.

It should also be understood that the terms “about,” “approximately,”“generally,” “substantially” and like terms, used herein when referringto a dimension or characteristic of a component of the invention,indicate that the described dimension/characteristic is not a strictboundary or parameter and does not exclude minor variations therefromthat are functionally similar. At a minimum, such references thatinclude a numerical parameter would include variations that, usingmathematical and industrial principles accepted in the art (e.g.,rounding, measurement or other systematic errors, manufacturingtolerances, etc.), would not vary the least significant digit.

Vascular Occlusion Systems

Furthermore, while the invention is described as a balloon catheterocclusion system, it will be understood that the described variants ofthe preferred balloon catheter system may be used clinically for avariety of different therapeutic or diagnostic indications involvingvascular interventions, including, for example and without limitation,arterial occlusion, angioplasty, stent delivery, atherectomy, drugdelivery, imaging or the like. In accordance with an exemplary andpreferred embodiment, the preferred balloon catheter system is wellsuited for use as an arterial occlusion balloon catheter, and inparticular an aortic occlusion balloon catheter. Applications makingadvantageous use of embodiments of the invention may use any suitableaccess site for vascular intervention. For example, applications of thecatheter system may involve access at the femoral artery, the brachialartery, the subclavian artery, or any other blood vessel suitable foruse as an access site for catheterization, including venous vessels.

Moreover, it will be understood that while a balloon is referred toherein as an example of occlusion member, other types of occlusionmembers are contemplated as being expressly within the scope of thepresent invention. In addition to balloons, the occlusion members mayinclude stents, coils, grafts, sheaths, cages, plugs, supported orunsupported membranes, or the like. The occlusion member, including theocclusion balloons, may be fabricated of biocompatible polymer orbiocompatible metal, or combinations thereof, and may be woven ornon-woven in structure. Biocompatible metals include, but are notlimited to, stainless steel, titanium, nitinol, cobalt, vanadium,aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon,magnesium, niobium, scandium, platinum, cobalt, palladium, manganese,molybdenum and alloys thereof, such as cobalt-chromium-molybdenum orzirconium-titanium-tantalum alloys. The metals and/or the polymers maybe elastic, shape memory or superelastic. More recent advanced materialsmay also be used, including carbon fibers, carbon nanotubes or carboncomposites, such as carbon/polyetheretherketone (PEEK). In the presentapplication, when the term “balloon” is used it is intended to mean afluid Tillable member capable of expanding from a first smaller diameterto a second larger diameter under the influence of fluid introduced intothe balloon. Unless otherwise stated, a balloon is not limited in size,shape, geometry, material or construction. When used in thisapplication, the term “occlusion member” is intended to be inclusive ofballoons and other structures, including stents, coils, grafts, sheaths,cages, plugs or supported or unsupported membranes.

In one aspect of the invention, a pressure relief apparatus for aballoon catheter is provided. The balloon catheter includes a shafthaving a balloon attached to the distal end of the shaft, aninflation/deflation lumen for inflating and deflating the balloon and apressure relief port. The pressure relief port may alternatively beformed through the wall of the inflation/deflation lumen, through thewall of the proximal hub, or may be part of the fluid pathway thatcouples to the proximal hub. A pressure relief member is secured eitheracross or within the pressure relief port to form a fluid tight seal.The fluid tight seal is configured to open or fail (e.g. open, burst,rupture, tear or leak) at a predetermined pressure to release pressurefrom the inflation/deflation lumen through the pressure relief port. Thepredetermined pressure may be less than or equal to the rated burstpressure of the balloon.

In one variation, the pressure relief port comprises a first outwardlyopening passage and a second passage in fluid communication with thefirst passage. The second passage extends inwardly from the firstpassage and opens into the inflation/deflation lumen. In this variation,the cross-sectional area of the first passage may be larger than thecross-sectional area of the second passage.

In one embodiment, a wall extends radially between an inside end of thefirst passage of the pressure relief port and an outside end of thesecond passage of the pressure relief port. The pressure relief membermaybe disposed adjacent the wall and across the outside end of thesecond passage of the pressure relief port to block the pressure reliefport and form a fluid tight seal. The pressure relief member may be aplastic film, a thin metallic film, a pop-off valve or other similarbiased valve. The bias of the pressure relief member is less than orequal to a predetermined pressure known to protect the device fromoverpressure and burst and to protect the patent from injury.

In another aspect, a pressure relief apparatus for a balloon catheterhaving a balloon with a rated burst pressure includes a proximal hubadapted for connection to a proximal end portion of a balloon cathetershaft wherein a pressure relief port is formed in the proximal hub. Inone embodiment, the proximal hub may comprise a plastic body thatdefines an inflation/deflation lumen and a may or may not include guidewire lumen or a working lumen.

The proximal hub may be formed from a substantially rigid material andincludes a wall defining the inflation/deflation lumen for directing afluid into and from an inflation/deflation lumen of the catheter shaft.In this alternative embodiment, the proximal hub includes a pressurerelief port formed through the wall of the hub and a pressure reliefmember disposed across or in the pressure relief port, forming a fluidtight seal across the pressure relief port. The pressure relief memberis configured to open or fail, (e.g. open, rupture, tear, burst orleak), at a predetermined pressure to release pressure from theinflation/deflation lumen through the pressure relief port.

In the case of an occlusion balloon, it is preferable that the balloonbe of a compliant or partially compliant balloon material and typicallyformed relatively distensible plastic or polymer material. The balloonsmay also be constructed of substantially compliant or partiallycompliant polymeric, biocompatible materials, such as PBAX or otherrelated polymers. The balloon may alternatively be constructed of anon-compliant material, which will typically expand less than about tenpercent (10%), and more typically less than about five percent (5%),when pressurized from their rated operating pressure to the balloon'srated burst pressure.

Where an occlusion balloon is the occlusion member, the proximal anddistal ends of the balloon may be attached to the catheter shaft usingtechniques known in the art, for example, with an adhesive such as amedical grade epoxy adhesive or may be reflowed to become an integralpart of the catheter shaft wall.

In the following description, when reference is made to the terms“proximal” or “proximally” it is intended to mean a portion or componentof the preferred vascular occlusion catheter system that is orientedaway from the body into which the system is or is intended to be placed.Conversely, when reference is made to the terms “distal” or “distally”it is intended to mean a portion or component of the preferred ballooncatheter system that is oriented toward the body into which the systemis or is intended to be placed. Thus, for example, the guidingatraumatic tip described hereinafter is located at a distal end of theballoon catheter system, while the proximal hub is located at a proximalend of the balloon catheter system.

As shown in the accompanying figures, the vascular occlusion cathetersystem 100 generally includes a catheter assembly having a firstcatheter member 130 having a first lumen 230, a second catheter member110 having a second lumen 210, a third catheter member 120 having athird lumen 220, an occlusion member 140, a proximal hub 190 and aguiding atraumatic tip 150. The first lumen 230 of the first cathetermember 130 extends longitudinally through the first catheter member andis coupled at its proximal end to the proximal hub 190 and at its distalend to a proximal section of the third catheter member 120 and incommunication with the third lumen 220 of the third catheter member. Thesecond lumen 210 of the second catheter member 110 also extendslongitudinally through the second catheter member 110, and terminates ina first port 160 distal to a proximal end of and within a space 142 atleast partially bounded by the occlusion member 140, best seen in FIGS.9 and 9A. Where the occlusion member 140 is a balloon, the second lumen210 is in communication with the space 142 bounded by the balloon 140and conveys inflation fluid to and from the balloon 140 from a sourceexternal to the balloon catheter system 100. The third catheter member120 is coupled at a proximal end thereof to a distal end of the firstcatheter member 130 such that the third lumen 220 of the third cathetermember 120 is in communication with the first lumen 230 of the firstcatheter member 130. As best seen in FIG. 1 , the second catheter member110 and the third catheter member 120 are positioned in longitudinalco-axial spaced apart relationship from one and other along alongitudinal axis 131 of the first catheter member 130 thereby definingan intermediate region 115 of the first catheter member 130 within thespace 142 that is not covered by either the second catheter member 110or the third catheter member 120.

When a balloon is the occlusion member 140, balloon 140 is attached, atits proximal end 144 to a distal end of the second catheter member 110and at its distal end 146 to a proximal end of the third catheter member120. Referring to FIGS. 2-5 , a proximal radio opaque marker 158 may beaffixed to the first catheter member 130 at or near the first port 160,which is near the attachment position of the inflatable balloon at theproximal end 144 of the balloon 140. A distal radio opaque marker 159may be affixed to the first catheter member 130 near the attachmentposition on the distal end 146 of the balloon 140. The proximal anddistal radio opaque markers 158, 159 may be implemented as bands made ofa radio opaque material. In one example, the radio opaque material is ametal that is radio opaque such as stainless steel, or an alloy, such asa platinum iridium alloy. In another example, the proximal and distalradio opaque markers 158, 159 may be sections of the catheters that havebeen impregnated with radio opaque material such as for examplestainless steel or a suitable alloy. In another example, the proximaland distal radio opaque markers 158, 159 may be implemented as bands orsections of plastic or a polymer such as PEBAX that has been mixed withbarium sulfate. The implementation of the proximal and distal radioopaque markers 158, 159 on the catheter system would aid invisualization of the balloon position within the vasculature usingfluoroscopy or x-ray.

When a balloon is used as the occlusion member 140, in operation,balloon 140 is inflated by introducing an inflation fluid, such assaline, from an external source, such as a syringe, coupled to theproximal hub 190, into and through the second lumen 210, out of thefirst port 160 and into the space 142 within the balloon 140. As isknown in the art, the inflation fluid is introduced until the balloon140 is inflated to a desired diameter or a desired fluid pressure of theinflation fluid is achieved, or both. Deflation of the balloon 140 issimply the reverse process of withdrawing the inflation fluid from thespace 142 of the inflation balloon 140. In its deflated or collapsedstate, the inflation balloon 140 will be positioned either within oradjacent to the intermediate region 115 of the first catheter member130, thereby providing a lower profile to the entire balloon cathetersystem 100.

When a fluid is used as the pressure source to activate the occlusionmember, such as to fill an occlusion balloon, that fluid may be aliquid, including water, saline, contrast medium or any combinationthereof, or may be a gas, including carbon dioxide, helium, air oroxygen. Catheter balloons may be inflated with gas, rather than liquid,because the balloon can be inflated and deflated more quickly than acomparable volume of saline or other liquid inflation media. Althoughair is relatively easy to load into an inflation device, air is not anideal inflation medium, because air does not rapidly dissolve in blood.In the event that the balloon bursts or leaks, bubbles could be formedin the arterial blood, impeding blood flow. In addition, as nitrogen isa chief component of air, nitrogen has thrombogenic properties that maypresent clinical risks in the event the balloon bursts. Accordingly, itis desirable to use a gas other than air and to prevent aircontamination of the gas used. A preferable gas used for ballooninflation is either carbon dioxide or helium.

As will be described in more detail hereinafter, with exemplaryreference to FIGS. 19-22 , the present invention also includesalternative embodiments of occlusion control systems that regulate theposition of the occlusion member 140 and the apposition of the occlusionmember 140 against a vascular wall surface. It is understood that whenthe occlusion member 140 is at least partially in non-apposition withthe vascular wall surface, that fluid flow or perfusion pas theocclusion member may or will occur. This fluid flow or perfusion may beof circulatory blood, or may be of fluids introduced through thepreferred vascular occlusion catheter system, or through another fluidintroduction system, such as a catheter.

The third catheter member 120 is depicted more particularly in FIGS. 4-5. The third catheter member 120 is coupled at its proximal endconcentrically about a distal end of the first catheter member 130. Aplurality of side ports 170 pass through a side wall of the thirdcatheter member 120 and provides fluid communication between the thirdlumen 220 and external environments proximate the external surface ofthe third catheter member 130, such as the inside of the patient's majorvessel when inserted into the patient. The distal end of the firstcatheter member 130 is preferably positioned within the third lumen 220and does not occlude the plurality of side ports 170, but terminatesproximal to the plurality of side ports 170 such that fluid may befreely communicated between the first lumen 230, the third lumen 220 andthe plurality of side ports 170 to either introduce fluid or withdrawfluid through the plurality of side ports 170. The plurality of sideports 170 may also be utilized for power injection of a contrast mediuminto the major vessel of the patient distally relative to the occlusionmember 140, as will be described in further detail herein. It will alsobe understood by those skilled in the art that maintaining fluidcommunication between the first lumen 230, the second lumen 220 and theplurality of side ports 170 also permits introduction of tetheredsensors, such as flow sensing wires, pressure sensing wires, ischemiasensors or the like to the distal end of the balloon catheter system100.

Finally, a guiding atraumatic tip 150 is coupled to a distal end sectionof the third catheter member 120. The guiding atraumatic tip 150 may bemade of an elastic, shape memory and/or superelastic material, such as ametal or polymer. A reinforcing member 152 (depicted in phantom) mayoptionally be included either within the guiding atraumatic tip 150 orwound about an external surface of the guiding atraumatic tip 150 tooffer additional reinforcement to the tip 150. A proximal end of theguiding atraumatic tip 150 is coupled to a distal end of the third lumen220 of the third catheter member 120 and a distal end of the guidingatraumatic tip 150 projects distally from the third catheter member 120and preferably has a generally circular profile when viewed from theside in a relaxed configuration. The atraumatic tip 150 preferablycurves proximally from the longitudinal axis 131 upwardly and then backtoward the central longitudinal axis 131 of the balloon catheter system100, but leaves an unconnected end 161 of the distal end of the guidingatraumatic tip 150 as it returns to a position proximate thelongitudinal axis 131. The atraumatic tip 150 is designed and configuredto permit the tip 150 to assume a linear or delivery configurationco-axial with the central longitudinal axis 131 of the balloon cathetersystem 100 for delivery and introduction into the patient's vesselthrough a catheter. Once the atraumatic tip 150 is introduced into thevessel and emerges from the introduction catheter, the atraumatic tip150 preferably returns to the relaxed configuration to inhibitintroduction of the catheter system 100 into smaller vessels as it movesinto the patient.

In the first embodiment of the preferred balloon catheter system 100illustrated in FIGS. 1-8 , the balloon catheter system 100, when theinflatable balloon 140 is in an uninflated condition, is of sufficientlysmall cross-segmental dimension to pass through a 6 to 8 French (2-2.67mm)-percutaneous sheath, such as, for example 7 French (2.33 mm). Thus,the balloon catheter system 100 has a greatest outer diameter, when theinflatable balloon 140 is uninflated, of less than 2-2.67 mm. It will beunderstood by those skilled in the art that the balloon catheter system100 is not limited to a dimension sufficient to pass through a 2-2.67 mm(6 to 8 French) percutaneous sheath, but that such lower profile orsmaller is generally considered desirable to enable passage of a ballooncatheter system 100 through tortuous vasculature and to a desiredposition within the body for purposes of arterial occlusion. The ballooncatheter system 100 is, therefore, not intended to be limited to thisdimensional size, but may be made of smaller or larger dimension asdesired or needed.

In one embodiment of the invention, the first catheter member 130 isformed of stainless steel metal and is radio opaque, in accordance withanother embodiment of the invention, it is constructed of nitinol and inaccordance with still another embodiment of the invention it is formedof biocompatible polymers. The first catheter member 130 lends columnarstrength to the balloon catheter system 100 and provides a functionalbackbone for carrying the second catheter member 110, the third cathetermember 120 and the inflatable balloon.

The outer diameter of the first catheter member 130 is smaller than theinner diameter of the second lumen 210 of the second catheter member110, thereby forming an annular space 212 between the outer surface ofthe first catheter member 130 and the inner surface of the secondcatheter member 110, as best shown in FIG. 7 .

In one embodiment of the invention, the distal end of the secondcatheter member 110 may have a tapering or narrowing diameter of theoutside surface and/or the second lumen 210 diameter. Preferably, thereis a minimal amount of narrowing on the second catheter member 110 andthe proximal lumen 210 to allow the annular space 212 to remainsufficiently large down the length of the second catheter member 110 topermit adequate flow of the inflation fluid through the annular space212.

Turning now to FIGS. 4-5 , the distal portion of the balloon cathetersystem 100 is illustrated. The first lumen 230 of the first cathetermember 130 may be used as a pressure monitoring line, such as by using afluid column therein to sense pressures through the plurality of sideports 170. The first lumen 230 may alternatively be used to introduce orwithdraw fluids, such as drugs, contrast media or blood through theplurality of side ports 170. Referring to FIG. 5 , the outer surface ofthe first catheter member 130 is coupled to at least a portion of theinner surface of the distal lumen 220, such that there is no annularspace between the outer surface of the first catheter member 130 and theinner surface of the second lumen 220. In one embodiment, the portion ofthe inner surface of the distal lumen 220 may be the length of thesecond lumen 220. Referring now to FIG. 4 , the third catheter member120 or the proximal shaft of the atraumatic tip 150 may include aplurality of segments of distally decreasing durometer polymer toprovide a step-down transition to the guiding atraumatic tip 150. Thenumber of step down durometer segments may be between one (1) and six(6) and may step down in decreasing fashion by regular or irregularincrements, such, for example 75D, 63D, 55D, 40D, etc. Alternatively,the third catheter member 120 may be made of a single durometer polymer,but having distally tapering wall thicknesses to impart a flexibilitygradient to the third catheter member 120. The plurality of segments ofdecreasing durometer plastic may be abutted and be bonded together ormay be manufactured from a single extrusion including decreasingdurometer hardness.

Referring now to FIG. 5 , the guiding atraumatic tip 150 is shown in itsunstrained and undeformed state as it would assume when in the body. Theguiding atraumatic tip 150 is used to minimize trauma to or perforationof the vasculature as the balloon catheter system 100 is advancedthrough the patient's tortuous anatomy, and to prevent departure from anintended vessel path, such as diversion into an undesired branch vessel.The size, shape and material of the distal section of the tip 150 aresuch that it will not pass into collateral vessels during delivery. Theguiding atraumatic tip 150 has a constrained state when passing throughan introducer sheath in which the distal section of the tip 150 issubstantially linear and co-axial with the longitudinal axis 131 of theballoon catheter system 100, and a relaxed state, as depicted, which isassumed upon exiting the introducer sheath and entering a blood vessel.In one embodiment, the guiding atraumatic tip 150 may be formed of anelastomeric, shape memory or superelastic material, including metals andpolymer. In another embodiment, the guiding atraumatic tip 150 may havea reinforcing elastic, shape memory or superelastic core 152 which aidsin transition between the unstressed state and the stressed state of theguiding atraumatic tip 150. In accordance with an exemplary embodimentof the tip 150, the outer diameter of the guiding atraumatic tip 150 (inthe relaxed state) may be between 1-7 mm, preferably between 2-6 mm andmost preferably between 4-6 mm.

Turning now to FIG. 6 , the proximal portion of the balloon cathetersystem 100 is illustrated. The second catheter member 110 is coupled tothe proximal hub 190 and the distal end of the first catheter member 130may be operably coupled to the proximal hub 190 at a proximal bondingsite using an adhesive 180 to bond an inner wall surface of the proximalhub 190 to an outer wall surface of the first catheter member 130. Asillustrated, the proximal hub 190 has two fluid pathways 192 and 194. Afirst fluid pathway 192 communicates with the first lumen 230 of thefirst catheter member and a second fluid pathway 194 communicates withthe second lumen 210 of the second catheter member 120. It will beunderstood that the proximal hub 190 may be configured to have more thantwo fluid pathways, with each fluid pathway communicating with adifferent lumen in the balloon catheter system 100. The first fluidpathway 192 of the proximal hub 190 may be connected to an externalpressure sensor, which would transduce pressure from a fluid columnwithin the first lumen 230 and through the plurality of side port 170(FIG. 5 ).

Referring to FIGS. 1-5 , in the first preferred embodiment, the ballooncatheter system or occlusion catheter system 100 also includes theplurality of side ports 170 positioned between the occlusion member 140and the atraumatic tip 150 in the third catheter member 120, theproximal shaft of the atraumatic tip 150 and/or the first cathetermember 130. The plurality of side ports 170 preferably facilitates powerinjection of a contrast medium into the patient's major vessel distallyrelative to the occlusion member 140 during use. Such power injectionmay be utilized for procedures such as angiography or arteriography. Inthe first preferred embodiment, the plurality of side ports 170 includea first side port 170 a, a second side port 170 b, a third side port 170c, a fourth side port 170 d, a fifth side port 170 e and a sixth sideport 170 f. The plurality of side ports 170 is not limited to includingsix (6) side ports 170 a, 170 b, 170 c, 170 d, 170 e, 170 f and theocclusion catheter system 100 may include more or less side ports 170 a,170 b, 170 c, 170 d, 170 e, 170 f and the plurality of side ports 170may be sized and configured in nearly any manner desired by the designerand/or medical technician for pressure sensing, power injection or otherrelated procedures utilizing the plurality of side ports 170.

Turning now to FIGS. 9 and 9A-9D, an alternative or second preferredembodiment of the balloon catheter system 300 is illustrated. Theballoon catheter system 300 includes generally a catheter assemblyincluding a first catheter member 310 having at least two lumens 210,330 passing longitudinally through the first catheter member 310, asecond catheter member 320 having a single lumen 230 passinglongitudinally through the second catheter member 320 and an inflatableballoon 140. The first catheter member 310 is coupled at its proximalend to a proximal hub 190 (not shown) and at a distal end thereof to aproximal end of the inflatable balloon 140. The second catheter member320 is coupled at its distal end to a proximal end of the first cathetermember 310 such that one of the first lumen 210 or the second lumen 330is in fluid flow communication with the second catheter member 320. Theother of the first lumen 210 or the second lumen 230 terminates at thedistal end of the first catheter member 310. For purposes ofillustration only and for clarity in the following description, it willbe assumed that second lumen 330 terminates at the distal end of thefirst catheter member 310 and has a distal port opening 160, it willalso be assumed that the first lumen 210 is in fluid flow communicationwith the second catheter member 320. As with the first embodiment of theballoon catheter system 100 described above, the second embodiment ofthe balloon catheter system 300, when the inflation balloon 140 is in anuninflated condition, is of a sufficiently small cross-sectionaldiameter to pass through a 6-8 French (2-2.67 mm)-percutaneous sheath,such as, for example, 7 French (2.33 mm). Thus, the balloon cathetersystem 300 has a greatest outer diameter, when the inflatable balloon140 is uninflated, that is less than 2-2.67 mm. It will be understood bythose skilled in the art that the balloon catheter system 100 is notlimited to a dimension sufficient to pass through a 2-2.67 mm (6 to 8French) percutaneous sheath, but that such lower profile or smaller isgenerally considered desirable to enable passage of a balloon cathetersystem 300 through tortuous vasculature and to a desired position withinthe body for purposes of arterial occlusion. The balloon catheter system300 is, therefore, not intended to be limited to this dimensional size,but may be made of smaller or larger dimension as desired or needed.

Referring now to FIG. 9A, the first catheter member 310 includes firstlumen 330 and a second lumen 210. The second catheter member 320includes a first lumen 220. The first catheter member 310 terminates atits distal end within the space defined under the balloon 140, where itis both coupled to the second catheter member 320 and terminates with anopen port 160 in fluid communication with lumen 330, permitting fluid tobe delivered to and from the balloon 140 for inflation and/or deflation.In accordance with an alternative embodiment, the distal end of thefirst catheter member 310 may, optionally, be tapered, such as bynarrowing the wall thickness of the catheter member 310 or by crimpingthe first catheter member 310 to a smaller diameter, thereby compressingand reducing the open area of the first lumen 330 and the second lumen210. If the first catheter member 310 is crimped to a tapered diameter,it is preferable that the extent of the crimping does not compress theopen area of the first lumen 330 and the second lumen 210 in a mannerthat significantly reduces fluid flow there through of fluid flowpressures therein, particularly with the second lumen 330 when it isused for the inflation fluid for the inflation balloon 140.

The third catheter member 130 is positioned within one of the firstlumen 210 or the second lumen 330 of the first catheter member 310. Asdepicted in the figures, this arrangement is illustrated with the thirdcatheter member 130 being positioned within the first lumen 210 of thefirst catheter member 310 and also within the first lumen 220 of thesecond catheter member 320. The outer diameter of the third cathetermember 130 is less than the inner diameter of the first lumen 210 of thefirst catheter member 310 as well as smaller than the inner diameter ofthe first lumen 210 of the second catheter member 320, such that anannular space 212 is formed therebetween as depicted in FIG. 9C. In themore distal region of the first catheter member 310, within the regionof the distal taper discussed above, the annular space 212 is compressedand either closes or is substantially closed to fluid flow, therebyeffectively sealing the distal end of the first lumen 210 near thetransition to the proximal attachment point of the inflatable balloon140, as depicted in FIG. 9A.

The third catheter member 130 passes longitudinally into the first lumen230 of the second catheter member 320 and has a first lumen 230 passinglongitudinally through the third catheter member 130. As with the firstcatheter member 130 of the first alternative embodiment described above,the first lumen 230 of the third catheter member 130 permits monitoringof conditions within the body, such as arterial pressure monitoring byhydrostatic pressure within a fluid column within the first lumen 230,or allows for the introduction of tethered sensors, such as flow sensingwires, pressure sensing wires or the like to the distal end of theballoon catheter system 300. First lumen 230 may also be used to deliverdrugs, contrast media, or permit the introduction or withdrawal offluids to and from the body.

As with the alternative embodiment discussed above with reference toFIGS. 1-8 , the embodiment depicted in FIGS. 9-9D may, optionally,include the second catheter member 320 being constructed of pluralsegments having distally increasing flexibility, such as by making thesegments of distally decreasing durometer polymer or fashioning thesecond catheter member 320 to have a distally tapering wall thickness.The second catheter member 320 may be formed of discrete segmentsabutted and coupled together to form an elongated second catheter member320 with either distally decreasing durometer or distally tapering wallthicknesses. Alternatively, the second catheter member 320 may be madeby extrusion or molding polymers of distally decreasing durometer ordistally tapering wall thicknesses.

As with the alternative embodiment of the balloon catheter system 100,the second catheter member 320 includes an open port 170 that is influid flow communication with the first lumen 230 of the third cathetermember. Similarly, as with the balloon catheter system 100, the ballooncatheter system 300 of the second preferred embodiment includes aguiding atraumatic tip (not shown in FIGS. 9-9D) as described above withreference to guiding atraumatic tip 150 of the first preferredembodiment, which is coupled to a distal end of the second cathetermember 320.

With reference to FIGS. 10 and 11 , there is depicted an alternativeembodiment of the guiding atraumatic tip 450. It will be understood thatguiding atraumatic tip 450 may be employed with any of the foregoingembodiments of the preferred balloon catheter system 100 or of thesecond preferred balloon catheter system 300. The guiding atraumatic tip450 is comprised generally of a polymeric cylindrical or tubular member452 that has a distal section 454 that has been formed into a generallyflattened cylinder having two generally planar opposing surfaces 455,457 and two generally curved opposing surfaces 458, 459. The twogenerally planar opposing surfaces 455, 457 include an inner planarsurface 455 and an outer planar surface 457. The distal section 454 hasa distally extending section 453 that projects distally and a curvedsection 456 continuous with the distally extending section that curvesaway from the central longitudinal axis 131 of the balloon cathetersystem 100, 300 then proximally toward the occlusion balloon 140 andsubtends a generally circular arc toward the central longitudinal axis131 of the balloon catheter system 100, 300. The angle of the curve maybe between about one hundred eighty degrees (180°) and three hundredfifty-five degrees (355°), more preferably between about two hundredseventy degrees (270°) and three hundred fifty degrees (350°) and evenmore preferably between about three hundred degrees (300°) and threehundred fifty degrees (350°) such that a gap is provided between theterminal end of the generally cylindrical flattened distal section 454and the more proximal surface of the distal section 454. It will also beunderstood that the distally extending section 453 and curved section456 may be formed as a generally in-plane circular shape or may beformed as an out-of-plane generally helical shape, where a terminal endof the curved section 456 is laterally displaced from the centrallongitudinal axis 131 of the balloon catheter system 100 or ballooncatheter system 300. In this manner, the generally flattened distalsection 454 is characterized by a generally circular profile. Theatraumatic tip 550 preferably operates in a manner similar to theguiding atraumatic tips 150, 350 of the previously described preferredembodiments, but is made of a polymer material without the need for areinforcing member 152, as described above.

In the preferred embodiment, a tip thickness T_(t) is defined betweenthe inner planar surface 455 and the outer planar surface 457 and tipwidth W_(t) is defined between the opposing curved lateral surfaces 458,459. The tip width W_(t) is preferably greater than the tip thicknessT_(t) such that the atraumatic tip 450 is readily flexible about acentral tip axis 450 a. The atraumatic tip 450 is preferably flexibleabout the central tip axis 450 a from the substantially circular profilein the relaxed configuration to the introduction configuration, whereinthe atraumatic tip 450 is relatively straight or positioned on thelongitudinal central axis 431. In the preferred embodiment, the tipthickness T_(t) is less than the tip width W_(t). The relatively smallertip thickness T_(t) in comparison to the tip width W_(t) facilitates theflexing of the atraumatic tip 450 from the relaxed configuration withthe substantially circular profile to the introduction configuration,wherein the atraumatic tip 450 is substantially straight and ispositioned on the longitudinal central axis 431 and renders bending ofthe atraumatic tip 450 laterally more difficult.

A tapered transition section 451 may, optionally, be provided betweenthe polymeric cylindrical or tubular member 452 and the generallyflattened cylindrical distal section 454. Guiding atraumatic tip 450 maybe integral with the third catheter member 120 of balloon cathetersystem 100 or the second catheter member 320 of balloon catheter system300. Alternatively, guiding atraumatic tip 450 may be fabricated as adiscrete member and joined to the third catheter member 120 of ballooncatheter system 100 or the second catheter member 320 of ballooncatheter system 300.

The guiding atraumatic tip 450, which may be made of polyether blockamide (PBAX, Arkema, Paris France) having a durometer of forty (40D), ora similar polymer, such as polyurethane or polyethylene, that iscompatible with the catheter shaft and balloon to make bonding easierand more secure. As discussed above, the guiding atraumatic tip 450 maybe either cylindrical or tubular, or have a solid cylindrical sectionand a tubular section. The curve of the guiding atraumatic tip 450 maybe made by any of a wide number of processes, including, for example,injection molding, round extrusion, flattening and post-processing intothe curved distal section 456, a flat extrusion bonded to a roundextrusion, or an extrusion that is pressed into a hot die having a shapeof the desired curved distal section 450.

The atraumatic tip 450 may include a radio opaque tip marker 460. Theradio opaque tip marker 460 may be implemented as a band surrounding thetip 450 or as a two-dimensional planar material on one or both of theplanar opposing surfaces 455. Alternatively, the radio opaque tip marker460 may be located at the most distal point of the atraumatic tip 450indicated at 460′ in FIG. 11 . The band or the planar material may becomposed of any suitable radio opaque material, such as for example,stainless steel or a suitable alloy such as platinum iridium. In anotherexample embodiment, the tip 450 may be made of a plastic or polymer,such as for example, PEBAX that is impregnated with a radio opaquematerial. In another example embodiment, the plastic or polymercomposition forming the tip 450 may be mixed with a radio opaquecompound such as for example barium sulfate sufficient to permitvisualization of the tip 450 using x-ray or fluoroscopy.

In an alternative embodiment described herein with reference to FIGS.12-18 , a balloon catheter system 500 generally includes a catheterassembly having a stiffener member 530, which is preferably comprised ofa solid wire, an inflation catheter member 510 having an inflation lumen610, a distal catheter member 520, an inflatable balloon 540, a proximalhub 590 and a guiding atraumatic tip 550. The stiffener member 530 issecured to the proximal hub 590 and extends longitudinally through theinflation catheter member 510 along the longitudinal axis 531 of thestiffener member 530, which substantially comprises the longitudinalaxis 531 of the catheter system 500. The stiffener member 530 includes aproximal end 530 b, a distal end 530 c and defines the longitudinal axis531. The stiffener member 530 is coupled at the proximal end 530 b tothe proximal hub 590 and at the distal end 530 c to a proximal sectionof the distal catheter member 520. The proximal hub 590 includes aninflation connection port 590 a with an inflation fluid pathway 594therein. The inflation lumen 610 of the inflation catheter member 510 isin fluid communication with the inflation fluid pathway 594 and extendslongitudinally through the inflation catheter member 510. The inflationlumen 610 preferably terminates at a first port 560 distal to a proximalballoon end 544 of and within a space 542 defined by the inflatableballoon 540, such that the inflation lumen 610 is in fluid flowcommunication with the space 542 within the inflatable balloon 540 toconvey an inflation fluid to and from the inflatable balloon 540 from asource external the balloon catheter system 500 that is preferablyconnected to the inflation connection port 590 a. The distal cathetermember 520 is coupled at a proximal end thereof to a distal end of thestiffener member 530. The inflation catheter member 510 and the distalcatheter member 520 are positioned in longitudinal co-axial spaced apartrelationship from one and other along a longitudinal axis 531 of thestiffener member 530, thereby defining an intermediate region 530 a ofthe stiffener member 530 within the space 542 within the inflatableballoon 540 that is not covered by either the inflation catheter member510 or the distal catheter member 520.

In this preferred embodiment of the balloon catheter system 500, whenthe occlusion balloon 540 is in an uninflated condition, the cathetersystem 500 is of sufficiently small cross-segmental dimension to passthrough a five to six (5-6) French (1.67-2 mm) percutaneous sheath, suchas, for example six (6) French (2 mm) introduction sheath. Thus, theballoon catheter system 500 has a greatest outer diameter, when theocclusion balloon 540 is uninflated, of less than 1.67-2 mm. The ballooncatheter system 500 of the preferred embodiment of FIGS. 12-18preferably has a smaller greatest outer diameter when the occlusionballoon 540 is uninflated than the above-described preferred cathetersystem 100 because of the solid stiffener member 530, which replaces thefirst catheter 130 with the first lumen 230 therein. It will beunderstood by those skilled in the art that the balloon catheter system500 is not limited to a dimension sufficient to pass through a five tosix (5-6) French percutaneous sheath, but that such lower profile orsmaller maximum diameter when the occlusion balloon 540 is uninflated isgenerally considered desirable to enable passage of a balloon cathetersystem 500 through tortuous vasculature and to a desired position withinthe body for purposes of arterial occlusion. In addition, the reducedmaximum diameter limits the size of the percutaneous introductionpuncture in the patient's skin and may limit the clinical requirementsfor the medical professionals performing the procedure. The ballooncatheter system 500 is, therefore, not intended to be limited to thisdimensional size, but may be made of smaller or larger dimension asdesired or needed.

In general, the alternative embodiment described herein with referenceto FIGS. 12-18 includes the stiffener member 530, preferably the solidwire, instead of a tube with a lumen. The solid stiffener member 530 maybe implemented as a solid flexible wire made of any suitable materialthat may be formed into a wire-like component. Examples of materialsthat may be used include polymeric materials, biocompatible metals,nitinol and stainless steel. The stiffener member 530 of this preferredembodiment may be constructed of a solid nitinol hypotube. The nitinolhypotube stiffener member 530 provides flexibility and sufficientstiffness along the longitudinal axis 531 and is generally a smalldiameter tube or wire. The stiffener member 530 implementation without alumen removes the fluid communication with a third lumen. The stiffenermember 530 does, however, allow for the implementation of a cathetersystem having a lower profile than the first embodiment of the cathetersystem 100.

In the alternative embodiment of FIGS. 12-18 , the catheter system 500preferably includes a pressure sensor 533 mounted distally of theocclusion balloon 540 or on a surface of the occlusion balloon 540proximate its distal balloon end 546. The pressure sensor 533 preferablycommunicates with a processor 501 that may be wired to the pressuresensor 533 or may receive pressure readings from the pressure sensor 533through wireless communication techniques. In the preferred embodiment,the pressure sensor 533 is wired to and in communication with theprocessor 501 by an electrical wire 533 a that carries pressure signalsfrom the pressure sensor 533 to the processor 501. The electrical wire533 a of the preferred embodiment extends at least partially through theinflation lumen 610 and is in electrical contact with the pressuresensor 533 and the processor 501. The preferred pressure sensor 533 ismounted to an external surface of the distal catheter member 520 tosample and detect pressures at the distal side of the inflatable balloon540. For example, the pressure sensor 533 may sample pressure near thedistal balloon end 546 of the inflatable balloon 540 during use andtransmit the pressure readings to the processor 501 for review by anoperator, medical technician or physician. The pressure sensor 533 mayalso be utilized to provide pressure measurements at predeterminedintervals to the processor 501. The processor 501 may adjust theinflation of the occlusion balloon 540 to permit limited flow throughthe vessel to the distal balloon end 546 of the occlusion balloon 540.The processor 501 may be controlled to maintain a range of pressures atthe distal balloon end 546 or a minimum pressure based on inflation anddeflation of the occlusion balloon 540.

Referring to FIGS. 12-18 , the inflatable balloon 540 is attached at itsproximal balloon end 544 to a distal end of the inflation cathetermember 510 and at its distal balloon end 546 to a proximal end of thedistal catheter member 520. In operation, the inflatable balloon 540 isinflated by introducing an inflation fluid, such as saline, from anexternal source, such as a syringe, coupled to the proximal hub 590,into and through the inflation lumen 610, out of the first port 560 andinto the space 542 within the inflatable balloon 540. Inflation anddeflation of the inflatable balloon 540 in FIGS. 1-8 is performed asdescribed above with reference to FIGS. 1-8 .

Referring to FIGS. 15 and 16 , the distal catheter member 520 is fixedlycoupled at its proximal end concentrically about a distal end of thestiffener member or solid wire 530. In the preferred example shown inFIG. 16 , the distal catheter member 520 has a lumen 620 extendinglongitudinally through the distal catheter member 520 and coupledconcentrically about a proximal end of the atraumatic tip 550. Thedistal catheter member 520 is not limited to including the lumen 620 andmay be configured as substantially solid between its proximal and distalend or integrally formed with or fixed to the atraumatic tip 550. Theguiding atraumatic tip 550 may be constructed of an elastic, shapememory and/or superelastic material, such as a metal or polymer. Areinforcing member 552 (depicted in phantom) may optionally be includedeither within the guiding atraumatic tip 550 or wound about an externalsurface of the guiding atraumatic tip 550 to offer additionalreinforcement to the tip 550. The guiding atraumatic tip 550 projectsdistally from the distal catheter member 520 and preferably has agenerally flattened configuration, curving proximally and then towardthe central longitudinal axis 531 of the balloon catheter system 500,but leaving a unconnected end 561 at the distal end of the guidingatraumatic tip 550. The atraumatic tip 550 is preferably designed andconfigured such that the atraumatic tip 550 is able to unfold from arelaxed configuration (FIG. 16 ) and assume a linear configurationco-axial with the central longitudinal axis 531 of the balloon cathetersystem 500 for delivery. During introduction, the atraumatic tip 550 ispreferably straightened along the longitudinal axis 531 in anintroduction configuration such that the atraumatic tip may bepositioned within a catheter for introduction and returns to thesubstantially circular-shape in the relaxed configuration when theatraumatic tip 550 emerges from the catheter in the patient's vessel.Specifically, the atraumatic tip 550 preferably has sufficientflexibility such that the substantially circular curve of the atraumatictip 550, in the relaxed configuration, may be straightened coaxiallywith the longitudinal axis 531 for introduction of the catheter system500 into the patient's vessel through an introduction catheter.

The atraumatic tip 550 of the preferred embodiment has a smallerthickness between the inner and outer planar surfaces 555, 557 than thelateral outer opposing surfaces 558, 559 of the atraumatic tip 550. Thisflattened shape of the atraumatic tip 550 facilitates the folding orflexing of the atraumatic tip along the longitudinal axis 531. The shapeand configuration of the preferred atraumatic tip 550 preferably limitsbending and folding of the atraumatic tip 550 laterally relative to thelongitudinal axis 531. In addition, the relatively flattened atraumatictip 550 provides manufacturing advantages when the atraumatic tip isconstructed of a polymeric material compared to the substantiallycylindrical atraumatic tip 150 shown in the first preferred embodiment.In the preferred embodiment, the lateral outer surfaces 558, 559 aresubstantially arcuate, but are not so limited and may be relativelyplanar or otherwise configured.

In the preferred embodiment, a tip thickness T_(t) is defined betweenthe inner planar surface 555 and the outer planar surface 557 and tipwidth W_(t) is defined between the opposing curved lateral surfaces 558,559. The tip width W_(t) is preferably greater than the tip thicknessT_(t) such that the atraumatic tip 550 is readily flexible about acentral tip axis 550 a. The atraumatic tip 550 is preferably flexibleabout the central tip axis 550 a from the substantially circular profilein the relaxed configuration to the introduction configuration, whereinthe atraumatic tip 550 is relatively straight or positioned on thelongitudinal central axis 531. In the preferred embodiment, the tipthickness T_(t) is less than the tip width W_(t). The relatively smallertip thickness T_(t) in comparison to the tip width W_(t) facilitates theflexing of the atraumatic tip 550 from the relaxed configuration withthe substantially circular profile to the introduction configuration,wherein the atraumatic tip 550 is substantially straight and ispositioned on the longitudinal central axis 431 and renders bending ofthe atraumatic tip 550 laterally more difficult.

The atraumatic tip 550 of the alternative preferred embodiment of thecatheter system 500 is preferably configured and functions similar tothe above-described atraumatic tip 450 of the preferred embodiment ofFIGS. 10 and 11 . The atraumatic tip 550 is preferably formed into thegenerally flattened frusta-cylinder having the two generally planaropposing inner and outer surfaces 555, 557 and two generally curvedopposing lateral surfaces 558, 559. The atraumatic tip 550 has adistally extending section 553 that projects distally and a curvedsection 556 continuous with the distally extending section 553 thatcurves away from the central longitudinal axis 531 of the ballooncatheter system 500 then proximally toward the occlusion balloon 540 andsubtends a generally circular arc toward the central longitudinal axis531 of the balloon catheter system 500. In the relaxed configuration,the atraumatic tip 550 preferably has a substantially circular profilewhen viewed from the side, but is not so limited and may have nearly anysized and shaped profile that limits introduction of the atraumatic tip550 into an alternative or smaller vessel path than desired by thephysician or medical professional. The angle of the curvature may bebetween about one hundred eighty degrees (180°) and three hundredfifty-five degrees (355°), more preferably between about two hundredseventy degrees (270°) and three hundred fifty degrees (350°) and evenmore preferably between about three hundred degrees (300°) and threehundred fifty degrees (350°) such that a gap 561 a is provided betweenthe unconnected end 561 of the generally cylindrical flattened distalsection 554 and the more proximal surface of the distal section 554. Thegenerally flattened section 554 provides manufacturing and functionaladvantage when compared to a cylindrical atraumatic tip, such as theatraumatic tip 150 described in FIGS. 4 and 5 . The flattened atraumatictip 550 of this alternative preferred embodiment permits flexibility ofthe atraumatic tip 550 about a plane or axis extending substantiallylaterally through the atraumatic tip 550, generally perpendicular to thelongitudinal axis 531 to accommodate straightening of the atraumatic tip550 coaxially with the longitudinal axis 531 for introduction. Inaddition, the greater lateral thickness of the atraumatic tip 550laterally relative to the longitudinal axis 531 provides stiffness tothe atraumatic tip 550 such that the tip 550 is more difficult to bendor flex out of its preferred shape laterally relative to thelongitudinal axis 531 during placement of the balloon 540 and movementof the catheter system 550 through the major vessels of the patient.

A tapered transition section 551 is preferably provided between asubstantially cylindrical portion of the distal catheter member 520 andthe generally flattened distal section 554. The preferred guidingatraumatic tip 550 is integral with the distal catheter member 520 ofballoon catheter system 500. Alternatively, the guiding atraumatic tip550 may be fabricated as a discrete member and joined to the distalcatheter member 520 of balloon catheter system 500.

The guiding atraumatic tip 550 is preferably constructed of a polyetherblock amide (PBAX, Arkema, Paris France) having a durometer of forty(40D), or a similar polymer, such as polyurethane or polyethylene, thatis compatible with the distal catheter member 520 and the balloon 540 tomake bonding easier and more secure. As discussed above, the guidingatraumatic tip 550 may be generally flattened, cylindrical or tubular,or have a solid cylindrical section and a tubular section. The curve ofthe guiding atraumatic tip 550 may be made by any of a wide number ofprocesses, including, for example, injection molding, round extrusion,flattening and post-processing into the curved distal section 556, aflat extrusion bonded to a round extrusion, or an extrusion that ispressed into a hot die having a shape of the desired curved distalsection 550.

The atraumatic tip 550 may include a radio opaque tip marker 560 a atthe unconnected end 561. The radio opaque tip marker 560 a may beimplemented as a band surrounding the tip or unconnected end 561 or as atwo-dimensional planar material on one or both of the planar opposingsurfaces 555, 557. The radio opaque marker 560 a may be constructed ofany suitable radio opaque material, such as for example, stainless steelor a suitable alloy such as platinum iridium. In another exampleembodiment, the tip 550 may be constructed of a plastic or polymer, suchas for example, PEBAX that is impregnated with a radio opaque materialto define the radio opaque tip marker 560 a. In another exampleembodiment, the plastic or polymer composition forming the atraumatictip 550 may be mixed with a radio opaque compound such as for examplebarium sulfate sufficient to permit visualization of the tip 550 usingx-ray or fluoroscopy to define the radio opaque tip marker 560 a.

As noted above in the description of the first preferred embodiment ofthe balloon catheter system 100 illustrated in FIGS. 1-8 , the ballooncatheter system 100, when the inflatable balloon 140 is in an uninflatedcondition, is of sufficiently small cross-segmental dimension to passthrough a 6 to 8 French (2-2.67 mm) percutaneous sheath, such as, forexample, 7 French (2.33 mm). Thus, the balloon catheter system 100 has agreatest outer diameter, when the inflatable balloon 140 is uninflated,of less than 2-2.67 mm. It will be understood by those skilled in theart that example implementations of the alternative embodiment of theballoon catheter system 500 described herein with reference to FIGS.12-18 may have an even smaller cross-sectional dimension due to the useof the stiffener member or solid wire 530 instead of a catheter with alumen. The diameter of the stiffener member 530 is smaller than theinner diameter of the inflation lumen 610 of the inflation cathetermember 510, thereby forming an annular space 612 between the outersurface of the solid stiffener member 530 and the inner surface of theinflation catheter member 510. The dimensions of the inner diameter ofthe inflation lumen 610 and the diameter of the stiffener member 530 maybe specified in example implementations to provide optimal inflationfluid flow as well as a reduced profile that may further easedeployment.

Turning now to FIGS. 14-16 , the distal portion of the balloon cathetersystem 500 is illustrated. As shown in FIG. 16 , the outer surface ofthe stiffener member 530 is coupled to at least a portion of the innersurface of the second lumen 620, such that there is no annular spacebetween the outer surface of the stiffener member 530 and the innersurface of the second lumen 620. Referring now to FIG. 15 , the distalcatheter member 520 may include a plurality of segments of distallydecreasing durometer polymer to provide a step-down transition to theguiding atraumatic tip 150. The number of step down durometer segmentsmay be between one (1) and six (6) and may step down in decreasingfashion by regular or irregular increments, such, for example 75D, 63D,55D, 40D, etc. Alternatively, the distal catheter member 520 may be madeof a single durometer polymer, but having distally tapering wallthicknesses to impart a flexibility gradient to the third cathetermember 520. The plurality of segments of decreasing durometer plasticmay be abutted and be bonded together or may be manufactured from asingle extrusion including decreasing durometer hardness.

In an alternative embodiment, the stiffener member 530 may extendcompletely into the space shown for the second lumen 620 such that thedistal catheter member 520 completely covers the distal end of thestiffener member 530. The atraumatic tip 550 may by formed as anextension of the second catheter body 520.

Turning now to FIG. 17 , the proximal portion of the balloon cathetersystem 500 is illustrated. The inflation catheter member 510 is coupledto the proximal hub 590 and the proximal end of the stiffener member orsolid wire 530 is fixedly coupled to the proximal hub 590 at a proximalbonding site, preferably using an adhesive 580, to bond an inner wallsurface of the proximal hub 590 to an outer wall surface of the solidstiffener member 530. The amount of adhesive 580 used is preferablysufficient to fixedly couple the solid stiffener member 530 to theproximal hub 590. As shown in FIG. 17 , the adhesive 580 may fill theentire portion 592 of the proximal hub 590 that holds the stiffenermember 530. The proximal end of the stiffener member 530 is not limitedto being adhesively bonded to the proximal hub 590 and may be otherwisefastened, secured or fixed to the proximal hub 590, as long as thestiffener member 530 is substantially secured to the proximal hub 590such that the stiffener member 530 provides stiffness for the ballooncatheter system 500, the stiffener member 530 is substantially securedrelative to the inflation catheter member 510 and the occlusion balloon540, the assembly is able to withstand the normal operating conditionsof the catheter system 500 and securement results in a structure able toperform the preferred functions of the catheter system 500, as isdescribed herein. Since the solid stiffener member 530 has no lumen, nofluid pathway is needed in the portion 592 that holds the stiffenermember 530 and the stiffener member 530 can have a relatively smalldiameter, thereby reducing the overall diameter of the catheter system500. As illustrated, the proximal hub 590 has an inflation fluid pathway594. The inflation fluid pathway 594 communicates with the inflationlumen 610 of the inflation catheter member 520. In this alternativepreferred embodiment, the inflation lumen 610 is defined between theouter surface of the stiffener member 530 and an inner surface of theinflation catheter member 510. It will be understood that the proximalhub 590 may be configured to have more than the inflation fluid pathway594, with each fluid pathway communicating with a different one of anyadditional lumens in the balloon catheter system 500.

It will be understood that when reference is made to coupling two ormore component sections, members or pieces of the balloon cathetersystem, that conventional catheter material bonding modalities areintended to be encompassed and employed. For example, a wide variety ofbiocompatible adhesives useful in catheter manufacture are known,similarly, thermobonding techniques used in catheter manufacture arealso known. Thus, for example, where it is described that the guidingatraumatic tip is coupled to the third catheter member or to the distalcatheter member, it is contemplated that such coupling may be made usingthermobonding, biocompatible adhesives or other methods of fixedlybonding two components in medical devices.

It will also be understood by those skilled in the art that it is wellknown to manufacture catheters of a variety of medical grade,biocompatible polymers, such as, for example and without limitation,silicone, nylon, polyurethane, PETE, latex, thermoplastic elastomers,polyether block amides (PBAX, Arkema, Paris, France). Alternatively, itis known to manufacture catheters of metals, such as nitinol orstainless steel. Similarly, it is known to manufacture catheters ofmetal-reinforced polymer, such as, for example and without limitation,stainless steel braiding over polyurethane, stainless steel helicalwindings over silicone or nitinol reinforced polymer. Thus, any or allof the first catheter member, the second catheter member, the inflationcatheter member, the distal catheter member, or the third cathetermember in any of the foregoing embodiments may be fabricated ofbiocompatible polymers, biocompatible metals or metal-reinforcedpolymers, as is known in the art.

It will also be understood by those skilled in the art that while theimplementation of radio opaque markers are described in the context ofembodiments described with reference to FIGS. 1-8 , it may be desirableto include radio opaque marker bands positioned at the proximal anddistal ends of the balloon in implementations of embodiments describedabove with reference to FIGS. 9-11 , and embodiments described abovewith reference to FIGS. 12-18 . It is also desirable to include lengthmarkers on the outer catheter shaft to indicate to the physician theinsertion depth of the balloon catheter system 100, the balloon cathetersystem 300, or the balloon catheter system 500. The length markers maybe printed or laser etched onto the outside of the catheter shaft.

In each of the foregoing described embodiments of the vascular occlusionsystems depicted in FIGS. 1-18 , the catheter may also include sensors,transmitters, receivers, interrogators or other means for measuringphysical and/or physiological parameters distal and/or proximal one ormore of the expandable occlusion members, including, for example bloodpressure sensors, heart rate sensors, flow sensors, chemical sensors,temperature sensors, oxygenation sensors, biological sensors, imagingsensors or the like.

The preferred catheters, sheaths, guide wires, balloons or otherocclusion members, or other components that are introduced into thevasculature may be coated with a variety of coatings, including withoutlimitation, antibacterial, antimicrobial, lubricants, anticoagulantand/or antifouling coatings. Thus, any or all components of any of thepreferred systems described herein may further include one or morebiocompatible coatings.

Occlusion Control System

Control over the apposition of the occlusion member against the vesselwalls is preferably accomplished by controlling the inflation of thepreferred balloons, selection of the size of the occlusion member,placement of the occlusion member or other methods and techniques thatprovide control to users of the preferred systems. Aortic occlusion mayresult in arterial hypertension upstream of an occlusion site aspressure builds against the occlusion member. If the arterial pressurereaches a deleterious hypertensive state, vascular rupture, stroke orother undesirable events may occur that could potentially injure thepatient. Conversely, after the vascular occlusion is complete and bloodflow is restored, there is a potential for concomitant drop in arterialblood pressure potentially leading to a hypotensive event that couldresult in a dangerously low blood pressure and, in extreme cases,cardiac arrest.

The preferred control systems are not limited to their utility with thepreferred vascular occlusion catheter systems 100, 300, 500 of thepresent invention, but may be used virtually with any type of vascularocclusion system. Thus, in FIG. 19 , there is shown a generic type ofvascular occlusion system 700, while in FIGS. 20-22 , the vascularocclusion catheter system is generically shown schematically and isdesignated by box 710, to denote a non-specific vascular occlusioncatheter system, including, for all of FIGS. 19-22 , without limitation,the first, second and third preferred vascular occlusion cathetersystems 100, 300, 500 described above. Other vascular occlusion cathetersystems that rely upon a pressure being applied to an occlusion memberto urge the occlusion member into apposition with a vascular wall,thereby at least partially occluding the blood vessel are expresslyincluded within the scope of occlusion control system of the presentinvention, such as the additional occlusion/perfusion systems describedherein.

In each of the preferred embodiments of the occlusion control systems,the pressure sources are denominated schematically by a generic box oroval to denote that a wide variety of pressure sources are intended tobe included within the preferred embodiments of the invention. Thepressure source may be a syringe or syringe-like inflation device, anendoflator device, a pump or other similar means of applying a pressureto the occlusion member in the vascular occlusion catheter 710. As notedabove, when a fluid is used as the pressure medium to activate theocclusion member, such as to fill an occlusion balloon, that fluid maybe a liquid, including water, saline, contrast medium or any combinationthereof, or may be a gas, including carbon dioxide, helium, air oroxygen. The fluid source may, in the instance of a liquid, be a liquidreservoir, a pre-measured volume of liquid in a vessel that is removablyengageable with the pressure source or other similar container forholding and dispensing liquid from the fluid source to the pressuresource. In the instance of a gas, the fluid source may be a gasreservoir or a pre-measured volume of pressurized gas in a canister thatis removably engagement with the pressure source to deliver thepre-measured volume of gas to the pressure source. A canister with apre-measured gas volume at a known pressure is also contemplated, forexample, a carbon dioxide cartridges that are commercially available ina wide variety of mass of pressurized gas, including without limitationeight, twelve, sixteen, twenty-five or thirty-three grams (8 g, 12 g, 16g, 25 g, 33 g). Converting mass to volume of a gas at standardtemperature and pressure (STP) typically entails resolving the gasconstant equation, as follows: V=nRT/P wherein V is volume, n is mass, Ris the molar volume of the gas, T is temperature (Kelvin) and P ispressure (atm). The volume of gas needed to inflate a specific occlusionmember to a given inflation volume and inflation pressure may becalculated utilizing this preferred formula.

Referring to FIG. 19 , a first embodiment of the occlusion controlsystem 700 includes a vascular occlusion catheter 711 has a proximal hub790 that includes at least one pressure line port 794. The pressure lineport 794 communicates with a pressure conduit or lumen 712 in thevascular occlusion catheter 711. The pressure conduit 712 may be a lumenwithin the vascular occlusion catheter 711 or may be a tubular conduitplaced within a lumen in the vascular occlusion catheter 711. A pressureaccumulator or reservoir 730 communicates with the pressure line port794 via pressure line 732 that is, in turn, coupled to a connectingconduit 720 associated with pressure line port 794. An actuator 744,such as a fluid pump, is coupled to the pressure accumulator 730 and toa fluid source (“FS”) 742. The actuator 744 is also operably coupled toa controller or central processing unit (“CPU”) 750. The controller 750operates as a computer control and may have an interface, not shown,that permits programming of computer control software that monitors andcontrols activation of the actuator 744 to regulate pressure in theocclusion member 740 and to collect data from sensors associated withthe occlusion control system 700.

In accordance the preferred embodiment of occlusion control system 700,the occlusion member 740 has a first pressure Pmax, which is below thefailure pressure of the occlusion member 740. The pressure accumulator730 is preferably pressurized, such as with a fluid, to an accumulatorpressure Pa, where the accumulator pressure Pa<Pmax, and where theaccumulator pressure Pa is less than a predetermined maximum safe bloodpressure Pbp within the vascular system being occluded, such thatPa<Pbp<Pmax. When the occlusion member 740 is in apposition with thevascular wall and the vessel is substantially occluded, the pressureexerted at the occlusion member 740 may be considered the appositionpressure Papp, wherein the apposition pressure Papp is substantiallyequal to the pressure in the accumulator 730 or the accumulator pressurePa. In this preferred embodiment, when during occlusion the bloodpressure Pbp against the occlusion member 740 exceeds the appositionpressure Papp, the accumulator pressure Pa in the accumulator 730 and inthe occlusion member 740 is exceeded and the occlusion member 740 mayyield to the blood pressure Pbp and release apposition against thevascular wall surface and allow fluid flow past the occlusion site.Since the apposition pressure Papp within the occlusion member 740 andthe accumulator pressure Pa within the accumulator 730 is preferably aclosed system, the pressure in the accumulator 730, such as theaccumulator pressure Pa, will rise and when blood pressure reduces to beless than the accumulator pressure Pa in the accumulator 730 and theapposition pressure Papp within the occlusion member 740, the occlusionmember 740 will preferably reestablish occlusion.

This effect of automatically adjusting apposition pressure Papp inresponse to an elevation in blood pressure Pbp, causing a release ofapposition against the vascular wall and, therefore, releasing theocclusion and permitting fluid flow past the occlusion site, in turnlowers the blood pressure head against the occlusion member 740. Whenthe blood pressure Pbp upstream of the occlusion member 740 hasdownwardly adjusted to below the accumulator pressure Pa and theapposition pressure Papp, the occlusion member 740, under the influenceof the elevated pressure in the accumulator 740, reestablishesapposition and, therefore, occlusion is reestablished. This cycle may belikened to “burping” as a pressure release.

One further aspect of the occlusion control system 700 illustrated inFIG. 19 , is that the preferred computer controller 750 preferablymonitors the accumulator pressure Pa, the blood pressure Pbp and theapposition pressure Papp and, when required, either automatically orafter providing audible or visual notification to a medical practitionerand input from the medical practitioner, actuates the actuator 744 todraw fluid from fluid source 742 and communicates the drawn fluid to theocclusion member 740 to increase the apposition pressure Papp.Conversely, where apposition pressure Papp is determined by the computercontroller 750 or by the medical practitioner to be too high, theactuator 744 may be controlled to withdraw fluid from the occlusionmember 740, lowering apposition pressure Papp and moving fluid from theocclusion member 740 to the fluid source 742.

The occlusion control system 700 is preferably a bidirectional systemcapable of increasing the occlusion pressure or apposition pressure Pappor decreasing the occlusion pressure or apposition pressure Papp undereither manual control or under control of the computer processor 750.Moreover, the preferred occlusion control system 700 is operable toautomatically release the apposition when the blood pressure Pbpimpinging on the occlusion member 740 is above a pre-determined level(typically that regarded as safe for the patient). Accordingly, theocclusion control system 700 preferably includes a pressure sensor thatis able to sense blood pressure on the proximal or distal side of theballoon 740 to measure the blood pressure Pbp impinging on the occlusionmember 740 and to adjust inflation pressure or apposition pressure Pappof the occlusion member 740 to at least partially control the bloodpressure Pbp in the vessel.

An alternative or second preferred embodiment of occlusion controlsystem 751 is depicted in FIG. 20 . In alternative or second preferredembodiment of the occlusion control system 751, the occlusion catheter710 is under control of a pressure source (“I”) 752, which in the caseof a fluid is coupled to a fluid source (“FS”) 751. Similar to the firstpreferred occlusion control system 700, the pressure source 752 may beunder manual control, under automatic control of a computer processor753, or under manual control interfacing with the computer processor753. A pressure conduit 754 preferably bifurcates into a free line 756and a regulated line 758. A check valve 760 is preferably positionedin-line in the regulated line 758. An actuable valve 762 is preferablyinterposed in both the free line 756 and the regulated line 758, and isoperable to select the free line 756, the regulated line 758 or both thefree line 756 and the regulated line 758. A fluid conduit 766 leads fromthe actuable valve 762 to the occlusion catheter 710. A pressure sensor764 may be interposed within fluid conduit 766 to monitor pressureduring operation of the second preferred occlusion control system 751and may alternatively be positioned in the occlusion control system 751to detect pressure at various locations relative to the system 751, suchas within an occlusion balloon or at proximal and/or distal ends of theocclusion balloon. The pressure sensor 764 may be a pressure gauge,electronic pressure sensor or pressure sensor that provides visualsignal to the medical practitioner directly or may feed a pressuresignal to the computer processor 753 that controls the occlusion controlsystem 751, in turn, upon the pressure signal and/or displays pressuredata to the medical practitioner.

Referring to FIG. 21 , there is shown yet another alternative or thirdpreferred embodiment of an occlusion control system 800. Unlike theocclusion control system 751 of the second preferred embodiment, thepreferred occlusion control system 800 preferably has a single pressureconduit communicating between the occlusion catheter 710, which isutilized herein as a generic occlusion catheter 710, and a pressuresource (“I”) 752, which, in the case of a fluid, is coupled to a fluidsource (“FS”) 801. Similar to the occlusion control system 700 of thefirst preferred embodiment, the pressure source (“I”) 802 of the thirdpreferred embodiment may be under manual control, under automaticcontrol of a computer processor 803, or under manual control interfacingwith the computer processor (“CPU”) 803. A pressure conduit 804preferably provides fluid communication between the pressure source 802and the occlusion catheter 710. A check valve 806 is preferably in-linewith the pressure conduit 804. The check valve 806 may be any type ofmanual or automatically actuatable valves that operate both to preventback-flow of an inflation fluid and as a pressure relief if there is anoverpressure in the occlusion catheter 710. A fluid conduit 866 leadsfrom the check valve 806 to the occlusion catheter 710. A pressuresensor 808 may be interposed within the fluid conduit 804, 866 tomonitor pressure during operation of the occlusion control system 800.The pressure sensor 808 may be a pressure gauge that provides visualsignal to the medical practitioner directly or may output a pressuresignal to computer control 803 that controls the occlusion controlsystem 800, in turn, upon the pressure signal and/or displays pressuredata to the medical practitioner. An additional feature of the occlusioncontrol system 800 may be the addition of a timer 810. The timer 810 ispreferably incorporated into the computer processor 803 or may bepositioned in-line with the fluid conduit 804, 866. The timer 810preferably communicates a time signal to the check valve 806, to thecomputer control 803 and/or to the pressure source 802, as indicated bydashed lines in FIG. 21 . The time signal may be a regular, consistentsignal representative of the timer status, or may be a single timeelapse signal that activates the check valve 806, the pressure source802 and/or the CPU 803 to withdraw pressure communicated to theocclusion catheter 710. Similarly, the timer 810 may issue a series oftime signals according to a pre-programmed routine stored in the CPU 803or in the timer 810 itself, to control cycling of the pressure source802 and/or opening and closing cycles of the check valve 806.

In a fourth preferred embodiment of the occlusion control system 820,the pressure source 802 is again in communication with the occlusioncatheter 710 via a pressure conduit 826. An actuable valve 828 ispreferably in-line in the pressure conduit 826 and operates under theinfluence of a controller 822. The controller 822 is preferably operablycoupled, such as by electrical, mechanical or electromechanicalcoupling, to both the actuable valve 828 and to the pressure source 802.The controller 822 may also communicate with a computer control or CPU803. In this preferred embodiment, the actuable valve 828 is operableunder the control of the controller 822 to open or close to allowpressure from the pressure source 802 to be applied to the occlusioncatheter 710 or to withdraw pressure from the occlusion catheter 710,depending upon the pressure state at the occlusion member 740 of thepreferred occlusion catheter 710. Again, similar to the above-describedembodiments the pressure source 802 is operable to increase pressure ordecrease pressure applied to the occlusion catheter 710, such as bydrawing fluid from fluid source 801 and supplying the fluid to theocclusion catheter 710 to inflate the occlusion balloon 740. In thereverse, the pressure source 802 is operable to decrease pressure bydrawing fluid from the occlusion balloon 740, thereby deflating theocclusion balloon 740, releasing apposition and occlusion at thevascular wall and permitting perfusion past the occlusion member 740when the occlusion member 740 is positioned in the vessel.

Pressure sensors 764, 808 may be positioned external the occlusioncatheter 710, as shown in the second and third preferred embodiments ofFIGS. 20 and 21 , or may be incorporated in the occlusion catheter 710itself and be positioned distal the occlusion member 740 with either anelectrical connection at the proximal hub 790, may be wireless or may becomprised of pressure sensors positioned both distal and proximaterelative to the occlusion member 740 and external relative to theocclusion catheter 710 to sense pressure both distal relative to theocclusion member 740, proximal the occlusion member 740, within theocclusion member 740 and within the pressure line 804, 866, 826, 766proximal the occlusion member 740.

In each of the foregoing described preferred embodiments of theocclusion control systems 700, 751, 800, 820 depicted and described withreference to FIGS. 19-22 , the systems may also include sensors,transmitters, receivers, interrogators or other means for measuringphysical and/or physiological parameters distal and/or proximal one ormore of the expandable occlusion members, including, for example bloodpressure sensors, heart rate sensors, flow sensors, chemical sensors,temperature sensors, oxygenation sensors, ischemia sensors, biologicalsensors, imaging sensors or the like.

Occlusion/Perfusion Systems

The preferred occlusion control systems 700, 751, 800, 820 describedabove function to control the apposition of the occlusion member 140,540, 740 against the vascular wall of the patient's vessel by regulatingthe pressure applied to the occlusion member 140, 540, 740. Thesepreferred systems 700, 751, 800, 820 regulate and mitigate bothhypertension and hypotension, by controlling the relative degree ofocclusion and perfusion, such as during and after a vascular repairprocedure. The occlusion catheter system 100, 300, 500, 700, itself, canalso be configured to regulate the degree of occlusion and perfusion.Referring to FIGS. 23-34 , there are provided alternative preferredocclusion balloon geometries that at least partially occlude thevascular lumen of the patient's vessel, thereby permitting at least apartial perfusion flow of blood past the occlusion site, if desired bythe physician or medical technician performing a procedure with thepreferred systems.

A first preferred embodiment of the occlusion/perfusion balloon system1200 is depicted in FIGS. 23-28A, a second preferred embodiment of theocclusion/perfusion balloon 1220 is depicted in FIGS. 29A and 29B, athird preferred embodiment of the occlusion/perfusion balloon 1230 isdepicted in FIGS. 30A and 30B, a fourth and fifth preferred embodimentof the occlusion/perfusion balloon system 1240 is depicted in FIGS.31-31B, a sixth preferred embodiment of an occlusion/perfusion balloonsystem 1260 is depicted in FIGS. 32 and 32A, a seventh preferredembodiment of the occlusion/perfusion balloon system 1270 is depicted inFIG. 33 , an eighth preferred embodiment of the occlusion/perfusionballoon system 1280 is depicted in FIG. 34 , a ninth preferredembodiment of the occlusion/perfusion balloon system 2000 is depicted inFIGS. 35A and 35B and a tenth preferred embodiment of theocclusion/perfusion balloon system 2100 is depicted in FIG. 35D.

Referring to FIGS. 23-28A, a balloon 1201 of the occlusion/perfusionballoon system 1200 of the first preferred embodiment is fabricated of asubstantially compliant biocompatible material, which may be a polymer,metal or composite material. The balloon 1201 of the occlusion/perfusionballoon system 1200 may alternatively be constructed of a substantiallycompliant material such that the balloon has a substantially definedshape in a fully inflated configuration that facilitates at leastpartial flow of fluid through channels 1206 a. The term “substantiallynon-compliant” is intended to mean a compliance range of about zero tofifteen percent (0-15%) of its expanded diameter when inflated to itsrated pressure. The balloon 1201 of the occlusion/perfusion balloon 1200is preferably constructed of polymeric balloon materials, including, butnot limited to, polyethylene terephthalate (“PET”), nylon, polyethylene,polyether block amides, such as PEBAX, polyurethane and polyvinylchloride. Highly compliant polymer materials may be made substantiallynon-compliant by incorporation of composite materials, such as carbonfibers or other substantially non-elastic materials, into or on thepolymer material of the preferred balloon 1201. Similarly, a compliantballoon material may be constrained by a substantially non-compliantmaterial, including polymer, metal or composite.

While the first preferred balloon 1201 is depicted in the accompanyingfigures in an elliptical-shape, it may have a different geometric shapethan elliptical, including, without limitation, spherical, elliptical,conical, square, rectangular, dog-boned, tapered, stepped, orcombinations thereof, such as, for example, conical/square orconical/spherical.

The first preferred occlusion/perfusion balloon system 1200 has aplurality of radially projecting members 1204 on the balloon 1201 whenthe occlusion/perfusion balloon system 1200 is in a partially-inflatedto nearly fully-inflated configuration. The projecting members 1204preferably project outwardly relative to a central longitudinal axis1200 a of the balloon 1201. Landing areas 1206 and channels 1206 a arepreferably defined between adjacent pairs of the projecting members 1204when the balloon 1201 is partially-inflated to nearly fully-inflated.The balloon 1201 has a proximal end 1208 and a distal end 1212 thatengage with and are joined to a proximal catheter member 1200 b and adistal catheter member 1200 c. The proximal catheter member 1200 bincludes an inflation lumen 1210 therein that facilitates inflation ofthe balloon. The balloon 1201 may be utilized with any of the preferredocclusion catheter systems 100, 300, 500, 700, 800, 1300, 1350 describedherein by mounting the proximal and distal ends 1208, 1212 to theassociated catheters. The first preferred balloon 1201 defines an openenvelope within the balloon 1201, which receives an inflation fluid orgas to expand the balloon 1201 from a collapsed configuration (notshown), wherein the balloon 1201 is folded to have substantially thesame diameter as the proximal and/or distal catheters 1200 b, 1200 c forintroduction into a patient's vessel, to its fully expanded state orinflated configuration (FIGS. 28 and 28A). In the inflatedconfiguration, the projecting members 1204 and landing areas 1206 arenearly, visually imperceptible from each other, as the balloon 1201 hasa substantially smooth, continuous outer surface shape in the inflatedconfiguration. In contrast, in partially inflated configurations (FIGS.23-27 ), the projecting members 1204 and the landing areas 1206 orchannels 1206 a are visually identifiable with the projecting members1204 typically positioned further from the central longitudinal axis1200 a than the associated landing areas 1206, with the channels 1206 adefined in the spaces between the projecting members 1204.

In this first preferred embodiment of the occlusion/perfusion balloonsystem 1200, the channels 1206 a of the balloon 1201 permit flow offluid and blood past the balloon 1201, substantially parallel or alongthe longitudinal axis 1200 a when the system 1200 is inserted into apatient's vessel. The balloon 1201 of the first preferredocclusion/perfusion system 1200 may take on numerous shapes, each withchannels 1206 a depending on the level of inflation. For example, in aminimal inflation configuration (FIGS. 23-25 ), the balloon 1201 hasrelatively deep and large channels 1206 a to accommodate relativelysignificant blood and fluid flow, in a low inflation configuration (FIG.26 ), the balloon 1201 has comparatively smaller channels 1206 a, in amedium inflation configuration (FIG. 27 ), the balloon 1201 has againcomparatively smaller channels 1206 a and, in a full inflationconfiguration (FIG. 28 ), the balloon 1201 does not include perceptiblechannels, such that the vessel may be completely occluded when theballoon 1201 is inflated to the fully inflated configuration.

The plurality of radially projecting members 1204 and landing areas 1206preferably extend along or substantially parallel to the centrallongitudinal axis 1200 a of the balloon 1201. The radially projectingmembers 1204 may be oriented substantially parallel to the longitudinalaxis 1200 a of the balloon 1201 or may extend at an angle relative tothe longitudinal axis 1200 a of the balloon system 1201. For example,the projecting members 1204 may spiral in a curved manner along anoutside surface 1200 d of the balloon 1201, such that the channels 1206a extend in a substantially spiral or arcuate orientation relative tothe longitudinal axis 1200 a. The angular orientation of the projectingmembers 1204 and landing areas 1206 are preferably sufficient to channelblood or fluid flow along the length of the balloon 1201 within thevessel and to generally not impede flow or contribute substantially tohighly disrupted blood flow that may result in thrombose. A preferredangular offset of the projecting members 1204 and landing areas 1206 maybe between zero and forty-five degrees (0-45°) relative to thelongitudinal axis 1200 a the balloon 1201. The radially projectingmembers 1204 may have either a generally linearly extending orientation,as is shown in the first preferred embodiment, a curvilinear orientationor nearly any other orientation that permits formation of the landingareas 1206 between the projecting members 1206 such that blood and fluidmay flow through the landing areas 1206 when the balloon 1201 isinserted in the vessel and is at least partially inflated.

In the first preferred embodiment, the occlusion/perfusion balloonsystem 1200 includes four (4) regularly arrayed radially projectingmembers 1204 on or incorporated into the balloon 1201. The balloon 1201is not limited to including four (4) regularly arrayed radiallyprojecting members 1204 and associated landing areas 1206 and the numberof radially projecting members 1204 may be any number greater than two(2) that permit blood and fluid to flow through the landing areas 1206when the balloon 1201 is in one of its partially inflated configuration.In the first preferred embodiment, there is sufficient surface area onthe radially projecting members 1204 to seat in apposition with avascular wall surface of the patient's vessel and that there issufficient surface area in the landing areas 1206 to channel fluid orblood flow along a length of the balloon 1201 when the balloon 1201 isin one of its partially inflated configurations, such as the partiallyinflated configurations of FIGS. 23-27 .

In the first preferred embodiment of the occlusion/perfusion balloonsystem 1200, each of the plurality of radially projecting members 1204has a generally circular or arcuate transverse profile, as depicted inFIG. 27 , on an upper aspect 1205 thereof, and a stem portion 1207 thatextends from the landing area 1206. The stem portion 1207 connects withthe upper aspect 1205 of each radially projecting member 1204 such thatthe stem portions 1207 have a smaller stem width than an upper aspectwidth (See FIG. 24 ). In the first preferred embodiment, the projectingmembers 1204 each have an apex 1218 that is preferably locatedintermediate a length of each radially projecting member 1204 orcentrally between the proximal end 1208 and distal end 1212 of thepreferred balloon 1201. The projecting members 1204 of the firstpreferred embodiment also preferably include a proximal, generallyflattened or planar area 1214 and a distal, generally flattened orplanar area 1216 on an outermost surface of each radially projectingmember 1204 relative to the central longitudinal axis 1200 a. Theproximal and distal generally flattened or planar areas 1214, 1216preferably extend proximally and distally, respectively, from the apexes1218. As will be seen from the series of FIGS. 23-28 , representing asequence of the balloon 1201 of the first preferred occlusion/perfusionballoon system 1200 with increasing degrees of inflation, the apex 1218forms the outermost equatorial circumference at the longitudinalmidpoint of the balloon 1201 along the longitudinal axis 1200 a. Theproximal and distal generally flattened or planar areas 1214, 1216facilitate diametric expansion and transition to the preferred fullyelliptical-like shape of the fully expanded balloon 1201 in its fullinflation configuration (See FIG. 28 ).

The first preferred embodiment of the occlusion/perfusion balloon system1200 may be constructed by forming the balloon 1201 of two or morematerials having differing hardness or moduli of elasticity. In thefirst preferred embodiment, as depicted in FIG. 28A, the balloon 1201may be formed such that the plurality of projecting members 1204 aremade of a higher durometer material, while the landing areas 1206 aremade of a relatively lower durometer material. These materials may beco-extruded or molded to define the preferred balloon 1201. In addition,the occlusion/perfusion balloon 1201 may be alternatively designed andconfigured with different materials that are able to take on the generalsize and shape of the occlusion/perfusion balloon 1201, particularly theminimal inflation, low inflation, medium inflation and full inflationconfigurations and related inflation configurations between theseconfigurations shown in the drawings, and withstand the normal operatingconditions of the occlusion/perfusion balloon 1201.

The size, shape and configuration of the plurality of projecting members1204 of the first preferred balloon 1201 is but one exemplary embodimentand may take on other various sizes, shapes and configurations. Asdescribed above, the plurality of projecting members 1204 are preferablyan integral part of the balloon 1201 itself, and form the wall surfacesof the balloon 1201. Alternatively, the projecting members 1204 may beelongate filaments, tubes, cylinders or other members that are eitherjoined to or integrally formed with an outer wall surface of theocclusion/perfusion balloon 1201. For example, the projecting members1204 may be constructed of a high durometer polytetrafluoroethylene(PTFE), fluorinated ethylene propylene (FEP), polyether block amide(PBAX) or other similar biocompatible material, formed in solid ortubular members having a circular, elliptical, quadrilateral, polygonalor other suitable transverse cross-sectional shape. These alternativeprojecting members 1204 may also be separately connected to the balloon1201 and separately inflatable and deflatable to control the inflationconfiguration of the occlusion/perfusion balloon 1201. The preferredprojecting members 1204 may be configured in nearly any shape, size andconfiguration such that the occlusion/perfusion balloon 1201 is able toselectively permit flow of fluid and blood past the projecting members1204, at least in certain inflation configurations, along thelongitudinal axis 1200 a. In addition, the occlusion/perfusion balloon1201 may be configured such that the channels 1206 are comprised of flowchannels or holes (not shown) that are surrounded by the material of theocclusion/perfusion balloon 1201 to permit flow of blood and fluidthrough or around the occlusion/perfusion balloon 1201 generallyparallel or along the longitudinal axis 1200 a.

Referring to FIGS. 29A and 29B, an occlusion balloon system 1220 inaccordance with a second preferred embodiment includes a balloon 1222with a plurality of projecting members 1224 projecting from an outerwall surface 1223 of the balloon 1222. The balloon 1222 is connected toa proximal catheter member 1220 b and a distal catheter member 1220 c,which may be incorporated into any of the preferred occlusion cathetersystems 100, 300, 500, 700, 1700, 1800, described herein. The proximalcatheter member 1220 b includes an inflation lumen therein thatfacilitates inflation of the balloon 1222. The projecting members 1224preferably extend substantially radially away from the outer surface1223 of the balloon 1222 and extend along the outer surface 1223substantially longitudinally relative to the longitudinal axis 1220 a.The preferred projecting members 1224 preferably extend along an entirelength of a substantially tubular section 1223 a of the balloon 1222,which tapers to the proximal and distal catheters 1220 b, 1220 c in asubstantially funnel-shape at its ends. The outer surface 1223 of theballoon 1222 preferably has a constant diameter in the tubular section1223 a. The projecting members 1224 are not limited to extendingsubstantially longitudinally along the entire length of the tubularsection 1223 a and the tubular section 1223 a is not limited to having asubstantially constant diameter and the balloon 1222 may be otherwisedesigned and configured such that the balloon 1222 is able to partiallyand fully occlude a vessel and withstand the normal operating conditionsof the preferred occlusion balloon system 1220.

The projecting members 1224 preferably define channels 1224 a betweenthe projecting members 1224 or adjacent the projecting members 1224 thatpermit flow of blood and fluid substantially parallel to thelongitudinal axis 1220 a when the occlusion balloon system 1220 ispositioned within a vessel. The balloon of the system 1220 may beinflated to various levels to enhance or reduce the channels 1224 a,depending on the preferred procedure, preferences of the medicaltechnician or conditions encountered or detected within the vessel.

Referring to FIGS. 30A and 30B, an occlusion/perfusion balloon system1230 in accordance with a third preferred embodiment includes a balloon1232 and a plurality of vanes 1234 that project from an outer wallsurface 1233 of the balloon 1232. In this third preferred embodiment ofthe occlusion/perfusion balloon system 1230, the vanes 1234 arepreferably resilient in nature and are capable of deforming or foldingover against an outer wall surface 1233 of the balloon 1232, as depictedby phantom lines 1238 (FIG. 30B), when the balloon 1232 is in appositionagainst a vascular wall surface and occluding the vessel or partiallyoccluding the vessel. The vanes 1234 of the third preferred embodimentalso preferably extend substantially radially away from the outersurface 1233 and extend along the outer surface 1233 substantiallylongitudinally relative to the longitudinal axis 1230 a. The vanes 1234preferably extend along an entire length of a substantially tubularsection 1233 a, which tapers to the proximal and distal catheters 1230b, 1230 c. The proximal catheter 1230 b includes an inflation lumentherein that facilitates inflation and deflation of the balloon 1232.The outer surface 1233 preferably has a constant diameter in the tubularsection 1233 a. The vanes 1234 preferably extend to tips 1234 a that arespaced at a greater distance from the outer surface 1233 when comparedto the similar projecting members 1224 of the second preferredembodiment. The outer surface 1233 of the balloon 1232 preferably has aconstant diameter in the tubular section 1233 a. The projecting members1234 are not limited to extending substantially longitudinally along theentire length of the tubular section 1233 a and the tubular section 1233a is not limited to having a substantially constant diameter and theballoon 1232 may be otherwise designed and configured such that theballoon 1232 is able to partially and fully occlude a vessel andwithstand the normal operating conditions of the preferred occlusionballoon system 1220.

In this third preferred embodiment of the system 1230, the vanes 1234preferably define channels 1234 b therebetween and with the walls of thevessel that permit flow of blood and fluid through the vessel along orsubstantially parallel to the longitudinal axis 1230 a. The channels1234 b may be manipulated or controlled by the user or designer by theinflation of the balloon 1232, the stiffness of the vanes 1234, theheight of the vanes 1234, the separation of the vanes 1234 and relatedother factors that may increase or decrease the size of the channels1234 b that facilitate flow of fluid through the vessel when the balloon1232 is inflated.

Referring to FIGS. 31-31B, fourth and fifth preferred embodiments of theocclusion/perfusion system 1240 includes a compliant occlusion balloon1242 and at least one restraining filament 1250 connected to proximaland distal catheters 1240 b, 1240 c with the restraining filament 1250positioned on an outside of an outer surface 1243 of the balloon 1242.The proximal catheter 1240 b includes an inflation lumen therein thatcarries fluid or gas to and from the balloon 1242 to facilitateinflation and deflation of the balloon 1242, respectively. Therestraining filament 1250 deforms at least one section of the occlusionballoon 1242 radially inward toward a longitudinal axis 1240 a of theballoon 1242 and away from the vascular wall or allows an adjacentportion of the balloon 1242 to extend further away from the longitudinalaxis 1240 a than the portion proximate the filament 1240. The inclusionof the restraining filament 1250 preferably creates a reverse curvaturein the balloon 1242 and permits fluid to flow past the balloon 1242,substantially parallel to the longitudinal axis 1240 a when the balloon1242 is positioned within the vessel. When a desired time elapses, adesired arterial blood pressure is achieved, or when other indicatorssuggest, the tension on the restraining filament 1250 may be released,the reverse curvature will expand and the balloon 1242 and the balloon1242 will return to its occlusion position in apposition with the vesselwall.

In the occlusion/perfusion system 1240 of the fourth preferredembodiment, the catheters 1240 b, 1240 c preferably accommodate the atleast one restraining filament 1250 within the catheter 1240 b, 1240 c,such that the filament 1250 exits the catheter 1240 b, 1240 c proximatethe balloon 1242, overlay the balloon 1250 along a portion of the lengthof the balloon 1250 and is configured to provide tension against theouter surface 1243 of the balloon 1250 to define channels or flow pathsalong the balloon 1250, preferably substantially parallel to or alongthe direction of the longitudinal axis 1240 a. In order to accommodatethis arrangement, the catheter 1240 b, 1240 c of the fourth preferredembodiment is provided with a distal port 1246 passing through the outerwall of the distal catheter 1240 c and a proximal port 1248 also passingthrough the outer wall of the proximal catheter 1240 b. The restrainingfilament 1250 is preferably lead from the proximal end of the proximalcatheter 1240 b, where it is accessible to the medical practitioner fortensioning, is passed through a lumen in the proximal catheter 1240 b(not shown), exits the proximal port 1248, passes over the balloon 1242and adjacent the outer surface 1243 of the balloon 1242, and anchor oris attached at the distal port 1246 to the distal catheter 1240 c. Inthis manner, tensioning the at least one filament 1250 at the proximalend of the proximal catheter 1240 b preferably causes the filament 1250to tension against the balloon 1242 or block expansion of the balloon1242 proximate the filament 1250. When the balloon 1242 is inflated, theportions of the balloon 1242 spaced from the filament 1250 expand awayfrom the longitudinal axis 1240 a, while the portions of the balloon1242 adjacent and beneath the filament 1250 are blocked from expansionby the filament 1250. Accordingly, the outer surface 1243 of the balloon1242 forms or defines channels 1254 extending substantially parallel tothe longitudinal axis 1240 a or along the length of the filament 1250between the expanded portions of the balloon 1242 between the filament1250 that permit fluid flow in the channels 1254 created between thevessel wall 1252 (shown in phantom in FIG. 31A) and the reverse curve ofthe outer surface 1243 of the balloon 1242.

Referring specifically to FIG. 31B, the fifth preferredocclusion/perfusion balloon system 1240 entails running the at least onerestraining filament 1250 within the interior space or within thematerial defined by the balloon 1242 and joining the at least onefilament 1250 to the inner wall surface of the balloon 1242. Thisjoining between the at least one restraining filament 1250 and the innerwall surface of the balloon 1242 may be accomplished by adhesives,thermobonding or reflowing. Alternatively, one or more lumens may beco-extruded with the inner wall surface of the balloon 1242 or tubularmembers joined to the inner wall surface of the balloon 1242, and the atleast restraining filament 1250 run within this at least one lumen ortubular member and anchored therein. The balloon 1242 may alternativelybe formed from different materials, with the filament 1250 beingconstructed of a stiffer material than the remainder of the balloon1242, such that the portion of the balloon 1242 with the filament 1240therein does not expand at the same rate or to the same extent as theremainder of the balloon 1242. In this fifth preferred embodiment,occlusion/perfusion balloon system 1240 does not necessarily include theproximal port 1248 and the distal port 1246, as the filament 1250 may bepositioned within the catheters 1240 b, 1240 c or within a lumen of thecatheters 1240 b, 1240 c. The filament 1250 would, therefore, typicallynot be exposed to the blood vessel or blood flow in such aconfiguration, as the filament 1250 would be encased within the balloon1242 and the catheters 1240 b, 1240 c, where the filament 1250 would nottypically be exposed to fluid and blood flow during use.

Referring to FIGS. 32 and 32A, a sixth preferred embodiment of anocclusion/perfusion balloon system 1260 includes a plurality of balloons1264 carried commonly on a catheter 1262. The plurality of balloons 1264may be incorporated with any of the preferred occlusion catheter systems100, 300, 500, 700, 1700, 1800, described herein. The plurality ofballoons 1264 are preferably independently expandable though inflationlumens or an inflation lumen 1265 in the catheter 1262. The inflationlumen 1265 preferably communicates independently with each one of theplurality of balloons 1264. The catheter 1262 preferably includes a sealmember 1266 movably mounted therein and a plurality of openings 1268that pass through the outer wall of catheter 1262 and communicate withthe fluid flow lumen 1265. The seal member 1266 is reciprocally movablewithin the fluid lumen 1265 and selectively occludes or opens one ormore of the plurality of openings 1268 in the outer wall of the catheter1262, thereby permitting fluid flow through the fluid flow lumen 1265and independently or concurrently into each of the plurality of balloons1264. In this manner, the volume and rate of fluid flow into theplurality of occluding balloons 1264 may be adjusted by the relativeposition of the seal member 1266 within the fluid flow lumen 1265.

Referring to FIGS. 33 and 34 , a seventh preferred embodiment of anocclusion/perfusion balloon system 1270 preferably does not rely upon anocclusion balloon or upon a fluid pressure to activate an occlusionballoon. Rather, in this seventh preferred embodiment, the occlusionmember consists of a supporting cage structure 1272 formed of aplurality of structural members, which may be longitudinally orientedstruts 1276 that taper distally, connect to a distal catheter member1274 and taper proximally where the struts 1276 connect to a proximalcatheter member 1275. An occluding membrane 1278 is preferably coupledto the supporting cage structure and may consist of a partial coveringon the supporting cage structure 1272 or may be comprised of a fullcovering (on the supporting cage structure 1272, as illustrated in FIG.34 with reference to occlusion/perfusion system 1280 of the eighthpreferred embodiment.

The struts of the supporting cage structure 1272 are preferably, fixedlycoupled at their distal ends to the distal catheter member 1274 and attheir proximal end are preferably, fixedly coupled to the proximalcatheter sleeve member 1275. The proximal catheter sleeve member 1275 isreciprocally movable relative to the distal catheter 1274. The relativemovement of the proximal catheter sleeve member 1275 relative to thedistal catheter 1274 preferably causes deformation of the supportingcage structure 1272 and allows the cage structure 1272 to diametricallyexpand or diametrically contract under the influence of such relativemovement. Such diametric expansion preferably brings the supporting cagestructure 1272 and the occluding membrane 1278 into an occlusiveposition within the lumen of a blood vessel, while diametric contractionpreferably reduces the diametric profile of the supporting cagestructure 1272 and the occluding membrane 1278, thereby allowing forfluid and blood flow past the occlusion site or past the cage structure1272.

The supporting cage structure 1272 of the seventh and eighth preferredembodiments, like a balloon, may assume a wide variety of geometries,including, without limitation, spherical, elliptical, conical, square,rectangular, dog boned, tapered, stepped, or combinations thereof, suchas, for example, conical/square or conical/spherical. The supportingcage structure 1272 and its struts 1276 may be made of any suitablebiocompatible material, including polymers, metals and/or composites orcombinations thereof. The biocompatible material may be an elastic,superelastic, shape memory material and is preferably able to take onthe general size and shape of the cage structure 1272, perform thefunctions of the preferred cage structure 1272 and withstand the normaloperating conditions of the cage structure 1272.

The occluding membrane 1278 preferably covers at least a portion of thesupporting cage structure 1272 in order to at least partially occludethe blood vessel into which the occlusion/perfusion systems 1270, 1280are placed. The occluding membrane 1278 may cover a proximal portion ofthe supporting cage 1272, a distal portion of the supporting cage 1272,the entire cage 1272, such as is shown in the eighth preferredembodiment (FIG. 34 ), or it may cover only portions of the cage 1272 topermit partial or partially occluded flow through the vessel. Thesupporting cage 1272 may facilitate pre-conditioning systems that infusefluid into the vessel to pre-emptively and prophylactically mitigatepossible ischemia during occlusion. The catheters 1272, 1275, 1284, 1285may include infusion holes 1284 a therein that facilitate infusion offluid into the vessel and the infusion holes 1284 may extend along allor a portion of the longitudinal length of the catheters 1272, 1275,1284, 1285. Furthermore, the occluding membrane 1278 may have an opening1279 in a proximal end to allow fluid flow therethrough to facilitatepartial occlusion and perfusion.

The occluding membrane 1278 is preferably constructed of a woven ornon-woven biocompatible material, such as polymers, metals, compositesand combinations thereof, and may be elastic, superelastic or shapememory. The occluding membrane 1278 may cover the outer surface of thesupporting cage 1272, the inner surface of the supporting cage 1272, orboth. The occluding membrane 1278 may be joined to the supporting cage1278 by sutures, biocompatible adhesive, by reflow, by thermal welding,or by joining to another layer of occluding membrane 1278 on theopposing surface of the supporting cage 1272 such that the struts of thesupporting cage 1278 are at least partially encapsulated by theoccluding membrane 1278. Methods and materials for joining the occludingmembrane 1278 to supporting cage 1272 may include adhesive bonding,fastening, clamping, co-molding and other related engagement techniques.

Referring to FIGS. 35A-35C, in a ninth preferred embodiment, anocclusion balloon system 2000 includes a balloon or inflatable occlusionmember 2001 with a plurality of projecting members 2002 projecting froman outer wall surface 2003 of the balloon 2001. The balloon 2001 isconnected to a proximal catheter member 2004 and a distal cathetermember 2005, which may be incorporated into any of the preferredocclusion catheter systems 100, 300, 500, 700, 1700, 1800, describedherein. The proximal catheter member 2004 includes an inflation lumentherein that facilitates inflation of the balloon 2001. The projectingmembers 2002 preferably extend substantially radially away from acentral longitudinal axis 2006 of the balloon 2001 and extend along theouter surface 2003 substantially laterally or circumferentially aroundthe longitudinal axis 2006. The preferred projecting members 2002preferably extend around an entire circumference of the balloon 2001,but are not so limited and may extend partially around the outer surface2003, may extend at angles relative to the longitudinal axis 2006, maybe comprised of various pockets on the surface 2003 or may be otherwiseconfigured to create spacing between a vessel 2008 and the outer surface2003, at least when the balloon 2001 is partially inflated. The balloon2001 of the ninth preferred embodiment includes four projecting members2002 longitudinally spaced along the length of the balloon 2001. The endprojecting members 2002 taper in an arcuate shape to connections withthe proximal and distal catheters 2004, 2005. The outer surface 2003 ofthe balloon 1222 preferably has a constant diameter at the peaks of theprojecting members 2002, but is not so limited and may have tapered orvariable spacing relative to the longitudinal axis 2006. Lateralchannels 2007 are preferably defined between the projecting members 2002when the balloon 2001 is at least partially inflated and are comprisedof circumferentially extending voids wherein the vessel 2008 is out ofcontact with the outer surface 2003 in the channels 2007. In contrast,when the balloon 2001 is fully inflated or is in an inflatedconfiguration, the balloon 2001 expands such that the outer surface 2003is substantially consistent and channels 2007 are not formed. In thisfully inflated configuration or at least close to the fully inflatedconfiguration, the outer surface 2003 is in direct contact with thevessel 2008 and fluid and blood flow are substantially occluded in thevessel 2008. The projecting members 2001 defined in at least thepartially inflated configuration are not limited to extendingsubstantially laterally or circumferentially around the longitudinalaxis 2006 and the projecting members 2002 are not limited to having asubstantially constant diameter. The balloon 2001 may be otherwisedesigned and configured such that the balloon 2001 is able to partiallyand fully occlude the vessel 2008 and withstand the normal operatingconditions of the preferred occlusion balloon system 2000.

The projecting members 2002 in the partially inflated configuration ofthe balloon 2001 preferably permit at least partial flow of blood andfluid substantially parallel to the longitudinal axis 2006 when theocclusion balloon system 2000 is positioned within the vessel 2008. Theballoon 2001 of the system 2000 may be inflated to various levels toenhance or reduce the channels 2007 and the position of the projectingmembers 2002 relative to the inner wall of the vessel 2008, depending onthe preferred procedure, preferences of the medical technician orconditions encountered or detected within the vessel. Generally, as thepressure is increased within the balloon 2001, the projecting members2002 come into closer positioning relative to the inner surface of thevessel 2008 and, therefore, limit flow of fluid and blood through thevessel 2008.

Referring to FIG. 35D, in a tenth preferred embodiment, anocclusion/perfusion balloon system 2100 includes a balloon or inflatableocclusion member 2101 with a spiral-shape projecting from a longitudinalaxis 2106 of the tenth preferred occlusion/perfusion balloon system2100. The inflatable occlusion/perfusion balloon 2101 includes channels2107 defined between projecting portions 2102 of the spiral-shapedballoon 2010 that permit flow of blood past the balloon 2101 wheninserted into the vessel and at least partially inflated. Similar to theninth preferred occlusion balloon system 2000, the tenth preferredocclusion/perfusion balloon system 2100 may be fully inflated within thevessel and substantially or completely occlude the vessel. The tenthpreferred occlusion/perfusion system 2100 also includes a proximalcatheter 2104 and a distal catheter 2105 connected to proximal anddistal balloon ends of the balloon 2101, which may be incorporated intoany of the preferred occlusion catheter systems and other preferredsystems having inflatable balloons or occlusion members describedherein.

In each of the foregoing described embodiments of theocclusion/perfusion balloon systems depicted and described withreference to FIGS. 23-35C, the systems may also include sensors,transmitters, receivers, interrogators or other means for measuringphysical and/or physiological parameters distal and/or proximal one ormore of the expandable occlusion members, including, for example bloodpressure sensors, heart rate sensors, flow sensors, chemical sensors,temperature sensors, oxygenation sensors, ischemia sensors, biologicalsensors, imaging sensors or the like. Data collection of the readingsfrom the sensors may be utilized with a controller or processor tocontrol inflation of the balloons or occlusion members of the preferredsystems to facilitate partial flow of fluid and blood through the vessel2008 when desired or to fully occlude the vessel 2008, as desired by themedical technician.

Pre-Conditioning Systems

Referring to FIGS. 36-37C, pharmacologically active agents, such aspressors, anticoagulants, anti-inflammatory agents, anti-hypertensiveagents, anti-hypotensive agents, anti-arrhythmic agents, or any otherindicated agent may be delivered using a fourth preferred embodiment ofand occlusion catheter system 1300 or a pre-conditioning system 1300.Larger volume infusions are also deliverable using the pre-conditioningsystem or the fourth preferred embodiment of the occlusion cathetersystem 1300, including blood, blood products, extracorporeal membraneoxygenation adjuncts, hypothermia adjuncts, saline, contrast or othertherapeutic or diagnostic agents.

A four preferred occlusion catheter system or pre-conditioning system1300 generally comprises a balloon catheter that has a plurality ofproximal side ports 1308 positioned proximal an occlusion member orballoon 1304 and a plurality of distal side ports 1310 positioneddistally relative to the occlusion member or balloon 1304. The pluralityof proximal side ports 1308 and the plurality of distal ports 1310 areoperable independently of each other to deliver fluids from the forthpreferred occlusion catheter system 1300 to the blood vessel into whichthe forth preferred system 130 is introduced. The pre-conditioningsystem 1300, synonymously termed “infusion system,” includes a secondcatheter member 1302 that is connected to a proximal hub 1301 attachedto a proximal end of the second catheter member 1302. The occlusionmember 1304 is coupled toward a distal end of the second catheter member1302. The occlusion member 1304, while depicted in FIG. 43 as a balloon,may be any type of member capable of vascular occlusion, such as thoseother embodiments of occlusion members disclosed herein or as are knownin the art.

The second catheter member 1302 has a second lumen 1303 passing along asubstantial longitudinal length of the second catheter member 1302. Thesecond catheter member 1302 also has at least one, but preferably theplurality of proximal side ports 1308 passing through an outer wall ofthe second catheter member 1302. The plurality of proximal side ports1308 is preferably in fluid flow communication with the second lumen1303. The plurality proximal side ports 1308 may be in a regular orirregular pattern and may be positioned about the circumference of thesecond catheter member 1302 or may have only a single orientationrelative to the central longitudinal axis 1331 of the infusion cathetersystem 1300.

A third catheter member 1320 of the fourth preferred occlusion cathetersystem 1300 extends distally relative to the occlusion member 1304 andterminates in an atraumatic tip 1306 or forms a proximal shaft orportion of the atraumatic tip 1306. The third catheter member 1320 has athird lumen 1322 passing along a substantial longitudinal length of thethird catheter member 1302, preferably along and coaxially with thelongitudinal axis 1331 near the distal end of the infusion cathetersystem 1300. The atraumatic tip 1306 is described above in greaterdetail with reference to the embodiments of the occlusion catheter 100,300, 500, and serves to guide the catheter system 1300 as it traversesthe vasculature and prevents the fourth preferred catheter system 1300from tracking into collateral vessels, while preferably eliminating theneed for a guide wire for placement of the occlusion catheter system1300. The occlusion catheter system 1300 may also incorporate theatraumatic tip 450, 550 of the second the third preferred embodiments ofthe occlusion catheter system 300, 500, as is described herein.

At least one of and preferably all of the plurality of distal side ports1310 pass through the outer wall of the third catheter member 1320 andcommunicate with the third lumen 1322 to communicate fluid distallyrelative to the occlusion member 1304. The plurality of distal sideports 1310 may be in a regular or irregular pattern and may bepositioned about the circumference of the third catheter member 1320 ormay have only a single orientation relative to the central longitudinalaxis 1331 of the infusion catheter system 1300.

In the fourth preferred embodiment of occlusion catheter system 1300where the occlusion member 1304 is a balloon, three lumens are preferredto service inflation of the occlusion member 1304 and fluid delivery toor sample collection from both of the plurality of proximal side ports1308 and the plurality of distal side ports 1308. At least one hypotubeor second catheter member 1312 is disposed within the second lumen 1303.Where the second catheter member or hypotube 1312 is employed, thesecond catheter member 1312 preferably has at least a first hypotubelumen 1314 and a second hypotube lumen 1316, with the first hypotubelumen 1314 configured to communicate an inflation fluid to the occlusionballoon 1304 and the second hypotube lumen 1316 configured tocommunicate fluid to the third catheter member 1320 and the plurality ofdistal side ports 1310 through the third lumen 1322, such that the thirdlumen 1322 is in fluid communication with the second hypotube lumen1316. The second lumen 1303, between the second catheter member 1312 andthe first catheter member 1302, preferably communicates fluid from theproximal hub 1301 to the plurality of proximal side ports 1308.

The at least one hypotube or second catheter member 1312 is preferablyconstructed of a material having different material properties than thefirst catheter member 1302 or the third catheter member 1320, such thatthe first lumen 1312 increases the column strength, pushability andpullability of the occlusion/infusion catheter system 1300 within thevasculature. In accordance with the fourth preferred embodiment of theocclusion catheter system 1300, the second catheter member 1312 isconstructed of a relatively strong metal, preferably stainless steel ornitinol. The second catheter member 1312 may alternatively beconstructed of a polymer, preferably a polymer having a higher hardnessthan that of either the first catheter member 1302 or the third cathetermember 1320, but is not so limited. The first catheter member 1302,second catheter member 1312 and third catheter member 1320 may also becombined in construction and configuration to have a transitioningstiffness, to include a separate stiffening member, such as a nitinolwire or braided shaft, to have sufficient pushability to have theappropriate amount of column strength.

Referring to FIGS. 37-37C, a fifth preferred embodiment of theocclusion/infusion system 1350 is generally similar to the infusionsystem or occlusion catheter system 1300 of the fourth preferredembodiment. The occlusion/infusion system or occlusion catheter system1350 of the fifth preferred embodiment employs a first hypotube 1362 anda second hypotube 1364 within a second lumen 1353 of a second cathetermember 1352. The second hypotube 1364 extends from the proximal end ofthe second catheter member 1352 and terminates in communication with theocclusion balloon 1354. Inflation fluid is communicated through a secondhypotube lumen 1365 of the second hypotube 1364, through an inflationport 1357 in the second catheter member 1352 that is positioned within aspace 1355 defined within the balloon 1354 and fills the space 1355 toinflate the balloon 1354. A seal 1349 is positioned within the secondcatheter member 1352 distal to the inflation port 1357 to seal thesecond lumen 1353 distally of the seal 1349 and permit the inflationfluid to flow through the inflation port 1357 and into the balloon 1354,but not distally of a distal end of the balloon 1354 in the second lumen1353. The first hypotube 1362 extends within the second lumen 1353 ofthe second catheter member 1352, extends beyond the seal 1349 andterminates within the third lumen 1368 in the distal portion of thesecond catheter member 1352 or a proximal portion of the atraumatic tip(not shown) to communicate with a plurality of distal side ports 1360.In this manner, fluid introduced into the first hypotube 1362 iscommunicated through the first hypotube lumen 1363 to the plurality ofdistal side ports 1360 for release through the plurality of distal sideports 1360 distal to the occlusion balloon 1354.

It will be appreciated, therefore, that fluids may be infused througheither the plurality of proximal side ports 1358 or the plurality ofdistal side ports 1360, independently, or through both, concurrently.The same or different infusion fluids may be infused through theplurality of proximal side ports 1358 and the plurality of distal sideports 1360, as well. The size, shape and position of the plurality ofproximal side ports 1358 and that of the plurality of distal side ports1360 may be configured to be the same or different and may be configureddepending upon the type of fluid being infused. Furthermore, theplurality of proximal side ports 1358, the plurality of distal sideports 1360, the first hypotube 1362 and the second hypotube 1364 may beconstructed of materials and tolerances suitable for powered injectionat higher pressures and flow rates.

Alternatively, an adjunctive or secondary infusion catheter, such asthose that are known in the art, that comprises a low-profile cathetershaft, a fluid connector at a proximal end of the catheter shaft and aplurality of fluid openings at a distal end of the catheter shaft, maybe engaged to pass within the second lumen 1353, down the length of thesecond catheter member 1352 and out of a port distal to the occlusionmember 1354. In this manner, the fourth and fifth preferred occlusioncatheter systems 1300, 1350 may or may not have the plurality ofproximal and distal side ports 1308, 1310, 1358, 1360, but may simplyemploy a secondary infusion catheter that is inserted into the secondlumen 1303, 1353 of the second catheter member 1302, 1352, or, where thepreferred occlusion catheter systems 1300, 1350 include the plurality ofproximal and distal side ports 1308, 1310, 1358, 1360, the secondaryinfusion catheter may be inserted into a lumen, for instance the secondhypotube lumen 1316, such that it will be able to extend a substantiallongitudinal length of second catheter member 1302, 1352 and deliverfluid through the plurality of distal side ports 1310, 1360.

Finally, it will be understood by those in the art, that the terminus ofthe third lumens 1322, 1368 may be configured to laterally guide aguiding tip of a guide wire or catheter out of either the plurality ofdistal side ports 1310, 1360 or out of a dedicated skive (not shown)formed in the distal wall surface of third catheter member 1320, 1370.

An alternative configuration of the fourth and fifth preferred occlusioncatheter systems 1300, 1350 may employ a secondary or adjunctiveinfusion catheter that is utilized for the primary occlusion, then asinfusion is required, to endoluminally delivery the secondary infusioncatheter laterally to the already placed occlusion catheter,diametrically collapse the occlusion member to permit luminal space forthe infusion catheter to pass the occlusion member, then reestablishocclusion when the infusion catheter is positioned distal to theocclusion member, thereby forming occlusion around the infusioncatheter.

In each of the foregoing described embodiments of the pre-conditioningsystems or the fourth and fifth preferred embodiments of the occlusioncatheter systems 1300, 1350 depicted and described with reference toFIGS. 35-36C, the systems 1300, 1350 may also include sensors,transmitters, receivers, interrogators or other means for measuringphysical and/or physiological parameters distal and/or proximal one ormore of the expandable occlusion members 1304, 1354, including, forexample blood pressure sensors, heart rate sensors, flow sensors,chemical sensors, temperature sensors, oxygenation sensors, ischemiasensors, biological sensors, imaging sensors or the like.

Hemorrhage Exclusion and Flow Restoration Systems

The foregoing described embodiments of the vascular occlusion cathetersystem operate by creating a luminal obstruction to blood flow to thehemorrhage site to at least partially stem the outflow of blood andpermit vascular repair of the hemorrhage site while preserving bloodflow to the patient's brain and other vital organs. Alternativeembodiments of the present invention operate to create an obstructionand occlude the hemorrhage site within the vascular wall. Moreover,rather than create luminal obstruction to blood flow, typically superiorto the hemorrhage site, these alternative embodiments, restore patencyof the blood vessel at the hemorrhage site and permit blood flow pastthe hemorrhage site while obstructing and occluding the trauma or injuryto the vessel wall itself.

FIG. 38 illustrates a first preferred embodiment a hemorrhage exclusionsystem 1400 in accordance with the present invention. The preferredhemorrhage exclusion system 1400 is conceptually similar toocclusion/perfusion system 1270 depicted in FIG. 33 . In the firstpreferred hemorrhage exclusion system 1400, an elongate supportstructure 1412 is formed of a plurality of structural support members,and is connected to a longitudinally extending catheter or cathetersleeve 1406. The structural support members, which may be longitudinallyoriented struts, form a distal cage section 1408 and a proximal cagesection 1402. The distal cage section 1408 is preferably, immovablycoupled to a distal end of the catheter 1406 and, when an atraumaticguiding tip 1404 is provided, proximal to the atraumatic guiding tip1404. The proximal cage section 1410 is coupled to the catheter sleevemember 1406. An intermediate cage section 1416 extends between theproximal cage section 1410 and the distal cage section 1408. Thehemorrhage exclusion system 1400 also includes an elongate supportstructure in the intermediate cage section 1416 that is preferablycomprised of a continuation of the structural support members of theproximal and distal cage sections 1410, 1408 with a large open volumewithin the support structure. The open volume between the structuralsupport members of the proximal cage section 1410 and distal cagesection 1408 facilitates blood flow longitudinally through the elongatesupport structure along the outside of the catheter sleeve 1406. Theelongate support structure—may be constructed of any appropriatebiocompatible material, including polymers, metals, composite materialsor combinations thereof, as discussed above with reference to theocclusion members.

An exclusion member 1414 is carried on the intermediate cage section1416 by the structural support members. The exclusion member 1414extends along at least a substantial extent of the intermediate cagesection 1416. The exclusion member 1414 may be fabricated of anyappropriate woven or non-woven biocompatible material, includingpolymers, metals, composite materials or combinations thereof, asdiscussed above in reference to the occlusion members. The exclusionmember 1414 may be plastically deformable, elastically deformable, orhave shape memory or superelastic properties. The exclusion member 1414is preferably, generally tubular and may be porous, non-porous orbio-absorbable. The exclusion member 1414 may be coupled to either theouter or inner surface of the elongate support structure 1412, or both.Coupling between the exclusion member 1414 may be in accordance with anymethods and materials for joining biomaterials to support structures,including, without limitation, sutures, biocompatible adhesive, byreflow, by thermal welding, or by joining to another layer of exclusionmember 1414 on the opposing surface of the support structure 1412 suchthat the struts of the support structure 1412 are at least partiallyencapsulated by the joined layers of the exclusion member 1414.

The catheter sleeve or catheter 1406 is preferably comprised of proximaland distal sections that are movably coupled to each other such thatrelative movement of the proximal and distal catheter sleeve members1406 translates to diametric expansion or contraction of the elongatesupport structure 1412 and the exclusion member 1414. The proximal anddistal portions of the catheter sleeve member 1406 are preferablycomprised of a tubular structure with a lumen through which an opposingcatheter passes. The catheter sleeve 1406 is not so limited and may beconstructed of nearly any assembly or construction that permits collapseand expansion of the elongate support structure 1412, wherein theelongate support structure 1412 has a similar diameter to the cathetersleeve 1406 in the collapsed configuration and has an expanded (FIG. 38) diameter that allows blood flow through the intermediate cage section1416 in the expanded configuration.

The elongate support structure 1412, may assume a wide variety ofgeometries, provided that the exclusion member 1414 supported on theelongate support structure defines a fluid flow pathway to restorepatency to the vessel and allow blood to flow past the hemorrhage site.

In use, the hemorrhage exclusion system 1400 is advanced to a hemorrhagesite. Contrast may be injected through the catheter 1406 and out of aport 1403 near the distal end of the catheter 1406 to image thehemorrhage, determine its position in the vessel wall and preferablyestimate its relative size. The exclusion member 1414 is preferablypositioned in such a manner as to span the hemorrhage site and extendboth proximal and distal relative to the hemorrhage site. The supportstructure 1412 and the exclusion member 1414 are diametrically expandedinto apposition with the vascular luminal wall surface, by relativemovement of the proximal and distal portions of the catheter sleeve1406. The exclusion member 1414 preferably blocks flow of blood out ofthe hemorrhage site and allows blood to continue to flow through thevessel and, preferably, preventing flow of blood out of the hemorrhage.Further imaging using injected contrast may be employed to verifysuccessful positioning of the exclusion member 1414 and coverage of thehemorrhage site to stem the outflow of blood from the vessel trauma orinjury. Alternatively or additionally blood pressure and/or blood flowdata may be obtained by pressure and/or flow sensors operably associatedwith the hemorrhage exclusion system 1400, to also verify successfulplacement of the exclusion member 1414 and restoration of vascularpatency and blood flow through the lumen of the exclusion member 1414,through the elongate support structure 1412 and through the vessel. Theexclusion member 1414 is preferably maintained in place blocking thehemorrhage site at least until the medical practitioner is able todevelop a plan to repair the hemorrhage.

An alternative preferred embodiment of the occlusion catheter system,which is similar to the foregoing hemorrhage exclusion system 1400 ofthe first preferred embodiment, involves eliminating the centralcatheter sleeve member 1406 and affixing the proximal cage section 1402to a more proximal section of the catheter 1406. A constraining sheath(not shown) is then placed over the catheter 1406, the elongatestructural support 1412 and the exclusion member 1414, constraining thestructural support 1412 and exclusion member 1414 in a reduced diametricstate until the constraining sheath is withdrawn. This configuration isparticularly well suited where the elongate structural support 1412 ismade of an elastic, shape memory or super elastic material. Thisalternate preferred embodiment is conceptually similar to the manner inwhich self-expanding or shape memory stents are endovascularly deliveredand placed.

Referring to FIGS. 39-39B, another or second preferred embodiment of theocclusion catheter system or hemorrhage exclusion system 1450 does notemploy an elongate support structure 1414, as is utilized in the firstpreferred embodiment of the hemorrhage exclusion system 1400. The secondpreferred system 1450 includes a catheter 1452 having a relativelylarger diametric profile which carries within a lumen in the catheter1452 a furled or rolled sheet of an exclusion material 1456. An elongatespindle member 1453 carrying a rolled sheet of exclusion material 1456is preferably positioned within a lumen of the catheter 1452. Thecatheter 1452 has an elongated slot 1455 passing through a wall surfaceof the catheter 1452. The exclusion material 1456 preferably has aleading edge that projects out of an elongate slot 1455 and, when theelongate spindle member 1453 is rotationally moved within the lumen ofcatheter 1452, the exclusion material 1456 unfurls or unrolls out of theelongated slot 1455. As the exclusion material 1456 fully unrolls fromwithin the catheter lumen, the exclusion material 1456 preferably formsa diametrically enlarged generally tubular structure with at least oneregion of overlap of the exclusion material 1456, such that a firstwinding of the exclusion material 1456 forms an outer layer 1459 of thetubular structure and a second winding of the exclusion material 1456forms an inner layer of the tubular structure. The tubular structure soformed defines a central lumen 1460 that allow blood flow through thetubular structure while the exclusion member 1456 is deployed in itsdiametrically expanded state.

In use, the hemorrhage exclusion system 1450 of the second preferredembodiment is endoluminally delivered to a hemorrhage site. Similar tothe hemorrhage exclusion system 1400 of the first preferred embodiment,the hemorrhage site may be imaged by contrast injection to position theexclusion system 1450 relative to the hemorrhage site. Once properlypositioned, the elongate spindle 1453 is rotatably actuated to unfurl orunroll the exclusion member 1456 through the elongate slot 1455 until itassumes its enlarged tubular shape and defines the blood flow centrallumen 1460 and is preferably in apposition with the vascular wallsurface and excludes or bypasses the hemorrhage site. Exclusion orbypass of the hemorrhage may be verified by contrast imaging or by bloodpressure and/or blood flow data obtained from the patient or from bloodpressure and/or blood flow sensors operably associated with, preferablyattached to the exclusion system 1450.

In each of the foregoing preferred embodiments of the hemorrhageexclusion systems 1400, 1450 depicted and described with reference toFIGS. 38-39B, the systems 1400, 1450 may also include sensors,transmitters, receivers, interrogators or other means for measuringphysical and/or physiological parameters distal and/or proximal one ormore of the expandable occlusion members, including, for example bloodpressure sensors, heart rate sensors, flow sensors, chemical sensors,temperature sensors, oxygenation sensors, ischemia sensors, biologicalsensors, imaging sensors or the like. The sensors may communicate with acontroller, which may control various aspects of the operation of thesystems 140, 1450, such as unfurling the exclusion member 1456 orcollapsing the exclusion member 1456.

Inflation Control Systems

Referring to FIG. 40 , a first preferred of an inflation control system1500 may be utilized with any of the preferred occlusion cathetersystems and other preferred systems having inflatable balloons orocclusion members described herein. In the first preferred embodiment,the inflation control system 1500 is preferably connected in-linebetween an inflation device (i.e. pressure source) and the ballooncatheter, such as the first preferred occlusion catheter system 100. Theinflation control system 1500 preferably helps to prevent the user fromoverinflating the balloon, such as the occlusion member 140 and damagingthe blood vessel into which the occlusion member or balloon 140 isinserted. The inflation control system 1500 preferably includes apressure source 1502, such as a syringe, which may be manually actuatedor may be coupled to any of a large number of known automated injectorsor pressure systems. The pressure source 1502 has a fluid sourcecontained within the syringe, and is coupled to a bifurcated pressureconduit 1506, that in turn communicates with a free line and a regulatedline. A one-way check valve 1508 is interposed in the regulated line toprevent both backpressure and backflow to the syringe 1502. A selectableflow valve 1504 is interposed in the free line and communicates with theregulated line. The selectable flow valve 1504 is operable to select thefree line, the regulated line or both the free line and the regulatedline. A fluid conduit leads from the selectable flow valve 1504 to apressure sensor 1510. A coupling 1512, preferably a luer lock fitting,is provided to couple the occlusion catheter (not shown) to the pressuresensor 1510. While an analog pressure gauge is shown in FIG. 55 , theanalog pressure gauge is not limiting and a wide variety of analog ordigital pressure sensors 1510 are capable of being used to provide themedical practitioner with information concerning the pressure in theinflation control system 1500.

In use, the inflation control system 1500 allows the practitioner toapply fluid pressure to the occlusion catheter, e.g., by advancing thesyringe plunger, to inflate the occlusion balloon, while simultaneouslypreventing both backpressure and backflow. When the selector valve 1504is positioned to open the regulated line and close the free line, fluidis free to flow through the check valve 1506 to the occlusion catheterand ultimately to the balloon. Pausing during inflation will not resultin deflation of the balloon because when force is no longer applied tothe syringe plunger, the fluid no longer advances through the checkvalve 1508 and the backpressure from the elastic balloon causes thefluid to try to exit the balloon/catheter, thereby causing the checkvalve 1508 to close.

The pressure sensor 1510 preferably senses the applied pressure at thepressure source 1502, but not necessarily at the occlusion balloon.Namely, because of the length of the occlusion catheter and the highresistance of the fluid passing through the narrow annular space of thecatheter shaft, the pressure at the pressure gauge 1510 may be higherthan the actual pressure in the balloon, but allowances and compensationmay be calculated to predict or measure the pressure within the balloonwith the gauge 1510. A dwell time typically exists between the timepressure is applied at the pressure source 1502 and when the pressureequilibrates at the occlusion balloon, but the pressure in the systembetween the check valve 1508 and the balloon quickly equalizes and thepressure sensor 1510 accurately reads the true pressure in the balloon.Excluding backpressure and backflow via the check valve 1508 creates aclosed system in which the pressure can be allowed to equilibrate, asrepresented by a constant pressure readout on the pressure sensor 1510,which will then represent the pressure at the occlusion balloon.Additional fluid pressure may then be applied at the pressure source1502.

As should be understood, the pressure sensor 1510 may have a “targetocclusion pressure” identified thereon (i.e. such as a blue zone of thegauge 1510) that the practitioner knows to keep inflating until theneedle comes a rest in the blue zone. This would indicate occlusion butnot over inflation. Therefore, since this system is based on pressureand not volume, it is not necessary to know the vessel diameter beforeinflating the balloon. Rather, the practitioner need only fill theballoon until the needle of the pressure gauge 1510 comes to a rest inthe “blue zone”.

Pressure may be withdrawn from the occlusion balloon by means of theselector flow valve 1504 being switched to open the free line,by-passing the check valve 1508, and releasing pressure back to thepressure source 1502 from the occlusion balloon. The syringe plunger ispreferably retracted and the fluid is drained from the balloon back intothe syringe 1502.

Referring to FIG. 41 , a preferred second embodiment of an inflationcontrol system 1550 is useful in the preferred inflation method of thepresent invention. A conventional balloon inflation device 1562 isillustrated in FIG. 41 (such as a QL Inflation Device, Atrion Medical,Arab, Ala.). The inflation device 1562 has a fluid chamber and a plunger1564. The plunger 1564 is preferably threaded to allow for rotation ofthe plunger 1564 relative to the fluid chamber and controlled depressionof the plunger 1564 within the fluid chamber. A fluid conduit 1563communicates with an outlet 1561 in the inflation device 1562 tocommunicate the inflation fluid to the occlusion catheter (not shown),such as the occlusion catheter system 100 of the first preferredembodiment or any of the other preferred occlusion systems describedherein, that is coupled to the inflation device 1550 via a coupling1561. A pressure sensor 1560 is preferably provided in the outlet lineof the inflation device 1550. A lock 1566 is preferably provided thatengages the threaded plunger 1564 during pressurization and disengagesfrom the threaded plunger 1564 during depressurization. The lock 1566acts, essentially, to isolate the pressure within the occlusion balloon,catheter and fluid conduit 1563 and resists transmitting backpressure orfluid backflow to the plunger 1564. Essentially, the lock 1566 functionsin a manner similar to the check valve 1508 in the preceding firstpreferred embodiment of the inflation control system 1500.

The method of inflating the occlusion balloon (not shown) using theinflation device 1562 entails the practitioner filling the fluid chamberwith an inflation fluid by withdrawing the plunger 1564 to fill thefluid conduit 1563 and the fluid chamber. Expelling any air present inthe fluid chamber and fluid conduit and connecting the inflation device1550 to the occlusion catheter (not shown). To inflate the occlusionballoon, the plunger 1564 is actuated either by linear force or byrotating the plunger 1564 to engage the threads for a controlledpressurization. The lock 1566 should be engaged with the plunger 1564 toresist backpressure as the balloon occlusion member inflates. Thepressure sensor 1560 will sense the applied pressure at the inflationdevice 1550, but not necessarily at the occlusion balloon. Because ofthe length of the occlusion catheter, a dwell time exists between thetime pressure is applied at the inflation device 1550 and when thepressure equilibrates at the occlusion balloon. By excludingbackpressure and backflow, the lock 1566 serves to creates a closedsystem in which the pressure can be allowed to equilibrate, asrepresented by a constant pressure readout on the pressure sensor 1560.When the pressure indicated on the pressure sensor 1560 is stable, thiswill then represent the pressure at the occlusion balloon. Additionalfluid pressure may then be applied or pressure may be withdrawn from theocclusion balloon by either reversing the rotation of the plunger,essentially unthreading the plunger 1564, and depressurizing theballoon, or by means of releasing the lock 1566 and withdrawing theplunger 1564.

The second preferred inflation device 1550 is not limited to thespecific arrangement described and shown herein and further mechanismsmay be employed to prevent the user/practitioner from overinflating theballoon and damaging the blood vessel or the balloon. For example, asshown in FIG. 41A, any of the preferred vascular occlusion cathetersystems, such as the first, second or third preferred occlusion cathetersystems 100, 300, 500, may include a spring biased valve 1501 positionedwithin the catheter, proximal the atraumatic guiding tip 150, 450, 550,including a plunger 1501 a sealingly engaging the catheter lumen andoccluding a port 1503 located distally therefrom. The spring 1501 bbiases the piston 1501 a into the position occluding the port 1503 andmay define a spring constant configured to be overcome by acounteracting force corresponding to a pressure equal to or less thanthe cracking pressure of the vessel. Therefore, prior to overinflatingthe balloon and damaging the vessel, the pressure within the catheterovercomes the spring 1501 b bias and pushes the plunger 1501 a distallyto expose the port 1503 and permit pressure release therethrough. Thespring 1501 b will push the plunger 1501 a back into the positionoccluding port 1503 once sufficient pressure is released.

Infection/Contamination Control System

Rapid endovascular occlusion or exclusion of a traumatic hemorrhagicinjury while on the battlefield or on the street involves not only anon-sterile environment, but an environment that is may be highlycontaminated and prone to a wide variety of sources of bacterial orviral infections. It is desirable to design, construct and deploy adevice that facilitates vascular access and endovascular delivery of avascular occlusion catheter while minimizing infections resulting fromcontamination when used in austere environments, i.e., on thebattlefield or on the street, rather than in a hospital or other sterileor controlled environment.

Referring to FIGS. 42A and 42B, a first preferred infection controlcatheter sleeve system 1600 provides a substantially sterile field forthe occlusion catheter 1602 and the occlusion balloon 1608 during accessand endovascular delivery and through the vascular occlusion procedure.The occlusion catheter preferably includes an inflation catheter 1602 apositioned proximate the balloon 1608 and a distal catheter member 1602b positioned distally relative to the balloon 1608. The inflationcatheter member 1602 a preferably has an inflation lumen similar to theinflation lumens described herein with respect to the preferredocclusion catheter members that has a port opening into an inner area ofthe occlusion balloon 1608 to permit inflation and deflation of theocclusion balloon 1608. The catheter sleeve system 1600 generallycomprises a sleeve 1610 that is preferably comprised of an elongatetubular structure fabricated of a highly resilient material capable ofbeing sterilized. The catheter sleeve 1610 is preferably a thin walled,elastic in inelastic polymer material that is capable of beinglongitudinally collapsed in an accordion-like fashion to ease insertionof the catheter 1602 into the sterile lumen of the elongate tubularstructure 1610 and thereafter elongated in an accordion-like fashion asneeded to cover substantially the entire shaft of the catheter 1602 in acovered configuration. The catheter sleeve 1610 preferably has hubmembers 1604, 1606 at respective proximal sleeve and distal sleeve ends1610 a, 1610 b of the catheter sleeve tubular structure 1610 that permitthe catheter 1602 to extend into and through the catheter sleeve 1600while generally maintaining hemostasis and a sterile field within thecatheter sleeve 1600. The preferred system 1600 includes proximal anddistal hub members 1604, 1606 that may be constructed and configured asany type of hemostatic valve that permits the catheter 1602 to passthrough the valve, such as, for example, without limitation, a TuohyBorst valve.

The distal hub member 1606 may also include surfaces, such as flanges,wings, or other projections from the distal hub member 1606 thatfacilitate close approximation with the patient's skin and applicationof a shield dressing or other adhesive dressing to retain the distal hubmember 1606, catheter sleeve 1600 and catheter 1602 positioned on thepatient after the occlusion catheter has been delivered.

In use, as the distal tip of the catheter 1602 is inserted into anintroducer sheath or the patient's body with the atraumatic tip 1605substantially straightened along the longitudinal axis 1601 and thedistal hub member 1606 of the catheter sleeve 1600 preferably remainsmated to the introducer sheath during insertion of the catheter 1602.The preferred thin polymer of the catheter sleeve 1610 collapses in anaccordion-like manner as the catheter 1602 is advanced into the body.Therefore, if something non-sterile comes into contact with the outsideof the catheter sleeve 1610, it generally does not contaminate thecatheter shaft 1602 that is inserted into the body. In addition, as thecatheter 1602 is withdrawn from the patient, the sleeve 1610 is able toexpand from its working configuration to the covered configuration suchthat materials, such as blood, from the vessel of the patient issubstantially maintained within the sleeve 1610 or is swiped from thecatheter 1602 by the distal hub 1606.

Guide Wire Compatibility

As indicated above, the vascular occlusion catheter systems, such as,for example, without limitation, the first, second and third preferredvascular occlusion catheter systems or occlusion catheter systems 100,300, 500, are preferably capable of use without the need for a guidewire 1700. Guide wires 1700 are typically designed to navigate vesselsto reach a desired vessel segment. Once the guide wire 1700 arrives atthe destination in the vessel, the guide wire 1700 acts as a guide thatfacilitates delivery of the catheter system to the destination vesselsegment. The atraumatic tip described above in detail with reference tothe preferred embodiments of the occlusion catheter system 100, 300,500, serves to guide the catheter as it traverses the vasculature andtypically prevents the catheter from tracking into collateral vessels,while preferably eliminating the need for a guide wire for catheterplacement.

Practitioners, may desire for the preferred vascular occlusion cathetersystems described herein to include guide wire capability forfamiliarity purposes. Accordingly, as shown in FIGS. 43 and 43A, aneighth preferred vascular occlusion catheter system 1701 is providedwith guide wire capability, while not requiring the guide wire 1700 foruse. In this preferred embodiment, the spiral or substantially circularshape of the atraumatic tip 1706, which is preferably configured in thesame manner as the atraumatic tips 450, 550 of the second and thirdpreferred embodiments, is positioned proximate an exit port 1702 of thecatheter system 1701. The atraumatic tip 1706 may alternatively beremoved and replaced with a distal end defining a substantiallystraight, compliant end and having the exit port 1702. The exit port1702 is in communication with a guide lumen 1703 defined in a tip shaft1705 of the atraumatic tip 1706. The guide lumen 1703 is preferablypositioned coaxially or substantially parallel and proximate alongitudinal axis 1707 of the catheter system 1701. The catheter system1701 preferably includes multiple lumens therein for inflation of anocclusion balloon 1708 and sliding receipt of the guide wire 1700.

In the preferred embodiment, the guide wire 1700 may be comprised of aneighteen thousandths of an inch (0.018″) to an approximately twenty-fivethousandths of an inch (0.025″) or thirty-five thousandths (0.035″)diameter guide wire 1700. The guide lumen 1703 and other lumens in thecatheter system 1701 are designed and configured to accept slidingacceptance of the guide wire 1700. The guide wire 1700 may be slidablyinserted and extend through the catheter system 1701, preferablycoaxially or proximate and substantially parallel to the longitudinalaxis 1707, and extend out of the distal end of the system 1701 throughthe exit port 1702. Accordingly, after the guide wire 1700 is insertedinto a patient's body, the catheter system 1701 is capable of advancingover the guide wire 1700 to reach the desired vascular destination andthe guide wire 1700 may subsequently be removed from the patient whileretaining the system 1701, particularly the occlusion balloon 1708therein.

The preferred catheter system 1701 includes a proximal hub (not show)that is the same or similar to the proximal hub of the herein describedpreferred embodiments. The proximal hub is connected to an inflationcatheter member 1709 that is positioned at a proximal end of theocclusion member or occlusion balloon 1708. The inflation cathetermember 1709 has an inflation lumen 1709 a therein that opens into aninternal space of the occlusion balloon 1708 at a first port 1709 b. Theinflation lumen 1790 a and inflation catheter member 1709 are preferablyposition on or along the longitudinal axis 1707. The occlusion balloon1708 preferably has a proximal end 1708 a and a distal end 1708 b,wherein the proximal end is connected to the inflation catheter member1709. A distal catheter member 1705, which may be comprised of the tipshaft 1705 or may be a separate catheter member is positionedsubstantially on the longitudinal axis 1707 and is connected to thedistal end 1708 b of the balloon 1708.

The atraumatic tip 1706 is connected to or formed integrally with thedistal catheter member or tip shaft 1705. The guide lumen 1703 is formedwithin the distal catheter member or tip shaft 1705 for slidable receiptof the guide wire 1700, preferably substantially along the longitudinalaxis 1707.

In the preferred embodiment, the catheter system 1701 may maintain thegenerally spiral or substantially circular shaped atraumatic tip 1706during insertion and the guide wire 1700 exits the catheter system 1701through the exit port 1702 below the atraumatic tip 1706 such that theguide wire 1700 may be initially inserted into the patient and thesystem 1701 is guided into position along the guide wire 1700. Thelumens of the preferred system 1701, including the guide lumen 1703 arein communication with the exit port 1702 and are appropriatelydimensioned to accommodate the desired diameter guide wire 1700. In thepreferred embodiment, the exit port 1702 is positioned on a lower sideof the atraumatic tip 1706, opposite the circular profile, such that thecircular profile is preferably oriented in its relaxed configurationafter insertion into the patient's vessel and during the guidingmovement into the appropriate location for the procedure in the vessel.

The catheter system 1701 of the eighth preferred embodiment may also beconfigured such that the exit port 1702 is located on an opposite sideof the atraumatic tip 1706 in the tip shaft 1705. Referring to FIGS. 43Band 43C, the alternative eighth preferred embodiment of the cathetersystem 1701′ has similar features when compared to the preferredcatheter system 1701 and like reference numerals are utilized toidentify and describe like features with a prime symbol (′) utilized todistinguish the eighth preferred embodiment from the alternativepreferred embodiment. In the alternative preferred embodiment, the exitport 1702′ is positioned proximate an inner tip surface 1709′ of theatraumatic tip 1706′ such that the guide wire 1700 would extend out ofthe alternative preferred system 1701′ into the inner surface 1709′ ofthe atraumatic tip 1706′. The guide wire 1700 is preferably sufficientlyflexible to deflect out of the way of the atraumatic tip 1706′ as itextends out of the exit port 1702′ to guide the catheter system 1701′ tothe appropriate location in the vessel and position the occlusion member(not shown) in the appropriate zone, such as zone I, II or II, as isdescribed above in the Summary of the Invention section. The alternativeeighth preferred embodiment otherwise operates substantially the same asthe eighth preferred embodiment of the system 1701 with the guide wire1700.

Power Injection Capability

Injecting contrast media into a patient's vasculature enables increasedvisualization using fluoroscopy. Contrast delivery is most effective andefficient using a medical device called a “power injector” that can beprogrammed to deliver specific amounts of contrast agent at specificflow rates.

Referring to FIGS. 44 , in a ninth preferred embodiment, an occlusioncatheter system 1800 includes multiple or a plurality of side ports 1809to distribute contrast medium in the vasculature rapidly and evenly,preferably distally relative to an occlusion member 1808. At least oneside port 1809 (multiple side ports in the illustrated embodiment) is influid communication with a lumen, e.g., the first, second and/or thirdlumen as described above with respect to the preferred catheter systems100, 300, 500, 1300, 1350, accessible from the proximal hub (not shown),such as, for example, without limitation, the proximal hubs 190, 590,790. Accordingly, contrast medium pumped into the catheter 1800 from theproximal hub is dispensed from the plurality of side ports 1809 and intothe surrounding vasculature.

The catheter 1800 is preferably configured in a similar manner to theocclusion catheter system 100 with the first catheter member 130 havingthe first lumen 230, the second catheter member 110 having the secondlumen 210 and the atraumatic tip 150 with a proximal portion comprisedof the third catheter member 120 with the third lumen 220. The multipleside ports 1809 are preferably formed in the proximal portion of theatraumatic tip 150, the third catheter member 120 or the first cathetermember 130 and may also be formed in each of these components of thecatheter 1800. The plurality of side ports 1809 are in fluidcommunication with the first lumen 230 through the first catheter member130, which is preferably in fluid communication with a power injectionmechanism (not shown) through the first fluid pathway 192 in theproximal hub 190. The space within the occlusion member 1808 ispreferably in fluid communication with an injection mechanism, such asthe inflation control system 1500 through the second fluid pathway 194and the second lumen 210, which introduces pressurized fluid or gas intothe occlusion member 1808 through the distal port opening 160.

In the illustrated embodiment, the side ports 1809 are located distallyfrom the occlusion member 1808. The side ports 1809, however, may belocated proximally and/or distally of the occlusion member 1808 and thenumber of side ports 1809 may be determined according to the desireddispensing rate. The plurality of side ports 1809 may also be located ina single plane or in a circumferential manner around the catheter shaft.The plurality of side ports 1809 may also be utilized to withdraw fluidsfrom the patient's vasculature, such as, for example, for bloodsampling.

The lumen in fluid communication with the side ports 1809 may be ahypotube constructed of a metal (e.g., nitinol), a polymer, a reinforcedpolymer (e.g., braided), or a composite material in order to withstandpower injection pressures. The catheter hub, extension lines, andconnectors are also constructed of the appropriate polymer/compositematerial in order to withstand power injection pressures. For example,extension lines may be braid reinforced or otherwise reinforced towithstand the power injection pressures. The catheter 1800 is,therefore, capable of being used safely with a power injector forcontrast injections. The catheter 1800 may also be used forvisualization of hemorrhage using fluoroscopy by injecting visualizationagent into the patient and visualizing flow and, particularlyhemorrhage.

Infusion Catheter

Referring to FIG. 45 , an infusion catheter or occlusion catheter system1900 in accordance with a tenth preferred embodiment (not including anocclusion member) can be utilized to infuse and withdraw fluids from apatient's vascular system. Similarly to the occlusion catheter 100, 300,500, the infusion catheter 1900 includes a distal, curled/spiral,polymeric atraumatic tip 1906 to assist the catheter 1900 to track up ablood vessel and remain in the central lumen of the vasculature. Thecatheter shaft 1910 is configured to have an appropriate stiffness to bepushable without kinking, while also being sufficiently flexible to notdamage blood vessels. The catheter shaft 1910 may be constructed of apolymeric material, a metallic material, or a combination of plastic,metal, and composite materials (e.g., fiberglass, carbon fiber, nylon,etc.) to achieve the appropriate stiffness. The catheter shaft 1910 maybe approximately five French (5 Fr) or five and twenty-four hundredthsmillimeters (5.24 mm), but may alternatively be constructed in othersizes as necessary. Similarly, the diameter of the generally circularprofile of the atraumatic tip 1906 (discussed below) may also be sizedappropriately according to the destination vessel size. The atraumatictip 1906 is preferably designed and configured similar to the atraumatictips 450, 550 of the second and third preferred embodiments of theocclusion catheter system 300, 500, as is described above.

Similarly to the occlusion catheter systems 100, 300, 500 of the first,second and third preferred embodiments, the infusion catheter 1900 ofthe tenth preferred embodiments is intended to be used without a guidewire for rapid insertion. The combination of the atraumatic tip 1906 andcatheter shaft 1910 substantially negates the need for a separate guidewire, as is typically utilized in procedures introducing catheters,stents, screws or other devices into the patient. The infusion catheter1900 preferably has a single lumen 1912 connected to a hub (not shown),e.g., with a standard luer lock fitting (not shown) at the proximal endof the occlusion catheter system 1900. The occlusion catheter system1900 may alternatively be connected with a hub via any of numerousdifferent connectors/fittings, that are currently known or that laterbecome known.

The catheter shaft 1910 of the tenth preferred embodiment includes aplurality of side ports 1909 (a plurality of ports 1909 in theillustrated embodiment) proximal relative to the atraumatic tip 1906.The plurality of side ports 1909 is in fluid communication with thelumen 1912. A fluid may be injected at the catheter hub and exit intothe vasculature at the plurality of side ports 1909. The plurality ofside ports 1909 preferably assist in distributing the fluid evenly toprevent the fluid stream from causing damage to the blood vessel. Theplurality of side ports 1909 maybe be positioned in a single plane orspiral around the catheter shaft 1910 or may otherwise be arranged andconfigured to facilitate injection in a manner desired by the medicalprofessional or designer.

As explained above, the catheter shaft 1910 is preferably constructed ofa material capable of withstanding the pressures and flow rates of powerinjection for contrast visualization. The catheter shaft 1910 could bebraided or non-braided. The catheter 1900 may also be used for bloodpressure monitoring via an external pressure sensor or to withdrawfluids (i.e. blood sampling, blood filtration/oxygenation(extracorporeal membrane oxygenation (“ECMO”), etc.).

The infusion catheter 1900 may be used in combination with an occlusioncatheter system, but is not so limited. For example, an occlusioncatheter system could be placed in the right femoral artery and advancedto the aorta and the occlusion member inflated to occlude the vessel.The infusion catheter 1900 could be inserted via the left femoral arteryand used to infuse fluids (i.e. blood products, hyperoxygenatedperfusate, crystalloids, etc.). The infusion catheter 1900 could also beused with a power/hand injector to inject radiopaque contrast (CO2,Isovue, etc.) to visualize the hemorrhage.

The infusion catheter 1900 may be packaged with a pre-installed“peel-away sheath” that is used to straighten the atraumatic tip 1906for insertion into the valve of the introducer sheath or directly intothe blood vessel. The peel-away sheath is advanced distally to captureand straighten the atraumatic tip 1906 and then can be retractedproximally toward the catheter hub and peeled off the catheter shaft1910 if necessary.

Decision Support Systems

Intelligent systems are becoming widely accepted and are finding theirway into acceptance in medical diagnostics and in the performance andpredictive analysis of medical device clinical trials. Articles andpresentations have been given related to this subject matter.

An approach based on Bayesian statistics is an approach for learningfrom evidence as it accumulates. In clinical trials, traditionalstatistical methods may use information from previous studies only atthe design stage. Then, at the data analysis stage, the information fromthese studies is considered as a complement to, but not part of, theformal analysis. In contrast, the Bayesian approach uses Bayes' Theoremto formally combine prior information with current information on aquantity of interest. The Bayesian idea is to consider the priorinformation and the trial results as part of a continual data stream, inwhich inferences are being updated each time new data become available.

The Bayes theorem may be used to calculate the probability of coronaryartery disease based upon clinical data and non-invasive test results.Pre-test probabilities of disease are assigned based on clinical dataand the equation is used to calculate post-test probabilities aftermultiple sequential tests. When good prior information on clinical useof a device exists, the Bayesian approach enables this information to beincorporated into the statistical analysis of a given decisional matrix.

Good prior information is often available for medical devices because oftheir mechanism of action and evolutionary development. The mechanism ofaction of medical devices is typically physical. As a result, deviceeffects are typically local, not systemic. Local effects can sometimesbe predictable from prior information on the previous generations of adevice when modifications to the device are minor. Good priorinformation can also be available from studies of the device overseas.

Bayesian methods are usually less controversial when the priorinformation is based on empirical evidence such as data from clinicaltrials. Bayesian methods can, however, be controversial when the priorinformation is based mainly on personal opinion.

Bayesian analyses are often computationally intense. Recentbreakthroughs in computational algorithms and computing speed have,however, made it possible to carry out calculations for very complex andrealistic Bayesian models. These advances have resulted in an increasein the popularity of Bayesian methods. A basic computational tool is amethod called Markov Chain Monte Carlo (“MCMC”) sampling, which is amethod for simulating from the distributions of random quantities.

As the Bayesian predictive modeling scheme has become well known, it isuseful in conjunction with the various control systems of the presentinvention, as described above, as predictive analysis profiling during avascular occlusion procedure.

In connection with the present invention, the various preferredembodiments of the occlusion catheter systems and related components anddevices described herein, and the occlusion or the occlusion/perfusioncontrol over the vascular occlusion devices, is well suited to oversightand control using intelligent systems, such as those in which Bayesianprobability analysis is applied. In each of the above-describedembodiments, including without limitation, the vascular occlusiondevices, the occlusion catheter systems, the control systems forcontrolling apposition of the occlusion member against the vessel wallor for excluding the hemorrhage site, the pre-conditioning systems orthe occlusion/perfusion systems, both physical and/or physiological datais either acquired or is capable of being acquired. Acquisition ofreal-time physical and/or physiological data during an occlusionprocedure or during a vascular repair involving a vascular occlusionincludes, without limitation, blood pressure, heart rate, flow,chemistry, temperature, oxygenation, imaging or the like. In combinationwith prior data obtained from clinical practice guides, standard of careprotocols, process flowcharts, and other data acquired during priorprocedures, intelligent predictive analysis may be applied in softwareor firmware resident at the computer controllers, e.g., controllers 750,753, 803, to either automatically control the preferred systemsdescribed herein or to output intelligently processed information to themedical practitioner to aid in decision making during the occlusionprocedure.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described above without departing from the broadinventive concept thereof. For example, nearly any of the individualcomponents of the various embodiments may be incorporated with otherpreferred embodiments without departing from the spirit and scope of thepreferred inventions. The plurality of proximal and distal side portsmay be incorporated in nearly any of the preferred occlusion cathetersystems, the atraumatic tips may be mixed and matched with the variousembodiments of the occlusion catheter systems, nearly any of thepreferred occlusion members, such as the first preferred occlusionballoon system 1200 with the projecting members 1204 may be incorporatedwith any of the preferred occlusion catheter systems and other similararrangement of the disclosed features of the preferred systems may beemployed without departing from the spirit and scope of the disclosedpreferred inventions. It is understood, therefore, that the invention isnot limited to the particular embodiments disclosed, but it is intendedto cover modifications within the spirit and scope of the presentinvention, as defined by the appended claims.

We claim:
 1. An inflation control system for use with an occlusioncatheter having an inflatable occlusion member for at least partialocclusion of a patient vessel, the inflation control system comprising:a fluid source in fluid communication with the inflatable occlusionmember; a pressure source coupled to the fluid source and configured tomove fluid between the fluid source and the inflatable occlusion member;a controller operably coupled to the pressure source and configured to:i. receive at least one patient vital sign as feedback, and ii. operatethe pressure source to modulate an inflation volume of the occlusionmember based, at least in part, on the feedback.
 2. The inflationcontrol system of claim 1, wherein the pressure source is a fluid pump.3. The inflation control system of claim 1, wherein the fluid source isa liquid reservoir.
 4. The inflation control system of claim 1, whereinthe at least one patient vital sign includes at least one of systolic ordiastolic blood pressure.
 5. The inflation control system of claim 1,wherein the controller incorporates a timer, the controller beingfurther configured to control cycling of the pressure source based onthe timer.
 6. The inflation control system of claim 1, wherein thecontroller is configured to operate the pressure source to modulate aninflation volume of the occlusion member based on a combination of thefeedback and stored historical data acquired during prior procedures. 7.The inflation control system of claim 1, wherein the controller isfurther configured to provide one of visual, auditory, or tactilefeedback to a medical practitioner as signals for the medicalpractitioner to take one or more recommended actions based on the atleast one patient vital sign.
 8. The inflation control system of claim7, wherein the one of visual, auditory, or tactile feedback is informedby stored historical data acquired during prior procedures.
 9. Theinflation control system of claim 1, further comprising a valve disposedbetween the pressure source and the inflatable occlusion member, thevalve being configured to provide pressure relief in the event ofoverpressure in the occlusion catheter.
 10. The inflation control systemof claim 1, further comprising a pressure sensor mounted to theocclusion catheter distally relative to the inflatable occlusion member,the pressure sensor configured to detect pressure and transmit thedetected pressure to the controller as the feedback.
 11. The inflationcontrol system of claim 10, wherein the pressure sensor is wired to andin communication with the controller.
 12. The inflation control systemof claim 1, wherein the controller is configured to adjust the inflationvolume to permit limited flow through the patient vessel.
 13. Theinflation control system of claim 1, wherein the controller isconfigured to control a range of pressures at a distal end of theinflatable occlusion member.
 14. The inflation control system of claim1, wherein the controller is configured to maintain a minimum pressureat a distal end of the inflatable occlusion member.
 15. The inflationcontrol system of claim 1, wherein the feedback is comprised of aphysiological parameter measured distal or proximal relative to theinflatable occlusion member.
 16. The inflation control system of claim1, wherein the feedback is comprised of a physiological parametermeasured by a flow sensor.
 17. The inflation control system of claim 1,wherein the feedback is comprised of a physiological parameter measuredby a chemical sensor.